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How early should you engage a CDMO?
The key is knowing which CMC activities can move forward early, and which decisions need to remain flexible as evidence develops.
By Kevin Kane, CMC Sciences Director, Clinical Research, Thermo Fisher Scientific
Industry Perspectives
Originally published on BioPharma Dive on October 19, 2026.
Republished on Patheon.com with permission.
Bringing a new therapy into the clinic requires clinical, nonclinical, regulatory, and CMC activities to advance in parallel. In early development, getting drug in hand often sits on the critical path to toxicology studies and clinical trials, creating an understandable incentive to engage a CDMO and begin CMC work as early as possible.
But starting early and committing early are not the same thing.
Clinical, nonclinical, and CMC strategies are closely interconnected. Decisions about indication, dose, formulation, route of administration, nonclinical studies, and clinical trial design can influence what is ultimately required from the CMC program. When these workstreams are planned separately against an idealized timeline, CMC decisions can get ahead of the evidence needed to support them.
The result can be rework that costs both time and money.
When moving quickly creates work that has to be repeated
One development program shows how quickly those early assumptions can change.
A biotech company developing a poorly soluble API worked with its CDMO to address the solubility challenge, moving quickly to produce an engineering batch using a solubility-enhancement approach.
The work, however, was based on a preliminary target product profile and was completed before pharmacokinetic (PK) and toxicology studies were finalized.
Those studies changed the picture. The nonclinical results indicated that much lower doses, without solubility enhancement, would allow the company to evaluate safety and tolerability, characterize the PK profile in Phase I, and better inform the strategy and product attributes for Phase II.
The CMC work therefore had to be repeated using a non-solubilized approach. Rather than accelerating the program, the early formulation decision added cost and delayed both the IND filing and the start of the clinical trial.
The lesson is not that the company engaged its CDMO too early. It is that a product decision was advanced before the evidence needed to support it was available.
Engage early, but know what needs to remain flexible
Early CDMO engagement can be valuable, particularly when it helps development teams understand technical requirements, dependencies, timelines, and potential risks. But engaging early does not mean every element of the CMC strategy needs to be defined at the outset.
Drug substance development, for example, can often move forward while some drug product decisions remain open. This is particularly important when a program is considering multiple indications, since the indication ultimately pursued can affect dosing regimens, routes of administration, and other product requirements.
In one recent program, a biotech company developing an injectable API took a phase-appropriate approach to product supply for its first-in-human study. Rather than advancing process and scale development before longer-term nonclinical studies were complete, the team moved forward with fit-for-purpose clinical supply. This supported an earlier IND submission and trial start while allowing emerging nonclinical and clinical data to inform later development decisions. Once safety and tolerability were established, the team could advance process and scale development for resupply with greater confidence.
The goal is not to wait until every uncertainty has been resolved. It is to distinguish between activities that can move forward with confidence and decisions that depend on clinical or nonclinical evidence still being generated. Maintaining flexibility around those decisions can help avoid committing time and resources to work that may need to change as the development strategy takes shape.
Optimize the development plan, not one workstream
That flexibility matters because the goal is not to optimize CMC in isolation, but to keep CMC aligned with the needs of the broader development program.
A CDMO can play an important role in that process, helping translate laboratory processes into scalable drug substance and drug product strategies, define CMC scope and budgets, and plan for clinical supply. But those plans need to evolve alongside the clinical and nonclinical strategy as new data refine or challenge early assumptions.
That requires ongoing communication across CMC, clinical, nonclinical, and regulatory teams so that decisions made in one area continue to reflect what is being learned in others.
The objective is not to advance every CMC activity as quickly as possible. It is to advance the right activities at the right time, while preserving flexibility where important development questions remain unresolved.
A faster CMC timeline does not accelerate development if new evidence ultimately requires the work to be done again.
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Scientific discussed the expectations and responsibilities of the UK and EU QPs in ensuring supply of clinical and commercial drug products between the UK and the EU. Their observations and responses to key questions are shared in this article.
Webinar
The future of decentralized clinical trials in an evolving EU regulatory landscape
The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research.
Webinar
The future of decentralized clinical trials in an evolving EU regulatory landscape
The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research.
Video
Solved with intelligence & imagination
When a client faced a complicated packaging challenge, Thermo Fisher Scientific’s Lead Account Manager went to the drawing board, literally.
Video
United with process & partnership
An experienced CDMO partner with an extensive network makes the difference when it comes to scale-up, tech transfer capabilities, and validation.
Webinar
An optimized approach to drug development
Take months off the development timelines of your large and small molecule discoveries.
Real-time Track and Trace platform for clinical trial shipments
Real-time Track and Trace platform for clinical trial shipments Real-time Track and Trace platform for clinical trial shipments Thermo Fisher Scientific’s Track and Trace solutions provide internal and external...
Article
Prepping for commercialization through supply chain logistics
Read the following article for insights on common supply chain challenges and considerations when preparing for commercialization of cell and gene therapy products.
Article
EU Clinical Trial Regulation 2022 –Impact on Regulatory, Labeling & QP
A panel of Thermo Fisher Scientific experts discuss the implications of the new EU Clinical Trial Regulation for pharmaceutical companies and their research and commercial partners
Infographic
Delivered with speed and service
An overview of our EU central pharmacy solution to support decentralized clinical trials in the EU – a step-by-step approach.
Webinar
COVID-19 Threatens Pharma’s Global Supply Chain. What Next?
Hear experts discuss how to navigate the current global supply chain challenges and what improvements Big Pharma and biotech firms should make from the COVID-19 outbreak moving forward.
Webinar
Comparator Strategic Sourcing Solutions
Join the webinar by Natalia Kozik, Program Manager, Comparator Sourcing to learn about Thermo Fisher Scientific’s comparator sourcing capabilities.
Webinar
Bulletproof Your Supply Chain: Hope for the Best, Prepare for the Worst
Incorporating a well-thought out contingency plan is critical when developing a clinical and commercial supply chain.
Webinar
Does Your Clinical Trial Design Satisfy the Needs of your Patients?
While patient-centric design increases convenience and provides an uninterrupted flow of medication for the patient, it can also positively impact trial enrollment and retention for Sponsors.
Webinar
Driving Supply Chain Productivity in Cell Therapy Clinical Trials
Learn about identifying risks in your cell or gene therapy clinical supply chain, mitigate risk and set yourself up for commercial success.
Webinar
Essential up-front planning for your clinical trial
Early, upfront planning of your clinical supply chain is critical to ensuring programs effectively balance risk and cost.
Webinar
EU Clinical Trial Regulation 2022 – Impact on regulatory, labeling and QP
Navigating the new regulatory changes is vital for successfully progressing complex clinical trials in the EU market and ensuring the timely supply of your Investigational Medicinal Products (IMPs).
Webinar
Importance of a one-stop-shop for clinical packaging and labeling in a GMP environment
Join the webinar by Robert Scarth, General Manager, Global Label Services, to learn importance of a one-stop-shop for clinical packaging and labeling in a GMP environment.
Webinar
Post-Pandemic Planning: What Will Change in the Clinical Supply Chain?
Watch as our clinical supply experts discuss the changes the clinical supply chain will face as a lasting result of COVID-19, how innovations from clinical service organizations such as Thermo Fisher will help move trials forward, and more.
Webinar
QP Release for drug products in Europe
Understanding regulatory legislation is vital for successfully navigating the complex global clinical trials market and ensuring the timely supply of your Investigational Medicinal Products (IMPs).
Webinar
QP release in the EU in 2022 and beyond: Your questions answered
In Europe, and in the UK, the Qualified Person (QP) plays a crucial role in bringing safe and timely products to the market and/or supplying them to the clinic.
Webinar
Transportation Solutions for Cell and Gene Therapy
From the basics such as service level expectations for couriers versus integrators, to how to evaluate domestic and international lanes, and finally—how to balance risk and cost, this webinar will help you understand how to start tackling your clinical supply chain.
Webinar
Your Clinical Results Look Promising, but are You Ready for Launch? How to Build a Robust Packaging Strategy for Rapid Commercialization
Now that you are starting to see promising clinical results, the focus quickly shifts to commercialization and the many challenges that come from planning a pharmaceutical packaging strategy.
Webinar
Smart packaging: The power of adherence data
The value of individual data points that are passively captured at each patient medication dosing event are often overshadowed.
eBook
Managing Temperature Excursions: Key Pointers That Must Be Addressed
Discover what to do when a temperature excursion occurs and get summary recommendations on how to handle cold chain or temperature sensitive IMP across the supply chain.
eBook
No Place like Home: How to Make Decentralized Clinical Trials a Win for Patients, Sponsors & Investigators
Download this eBook to learn about the integral role Direct-to-Patient Services play in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.
eBook
Ancillary Management: Keep Your Clinical Trial on Track
Learn the industry trends that are driving increased focus on a successful ancillary strategy and important considerations to develop a comprehensive strategy that minimizes risk.
eBook
Beyond Procurement: Taking a Strategic Approach to Comparator Drug Sourcing
Sourcing a comparator drug with the highest quality and with a short lead-time can be challenging. Find out how a strategic approach can help.
eBook
Cell Therapy Logistics: Advanced Therapy
Overview key considerations for developing a successful logistics strategy for the management of cell-based material.
eBook
Clinical Trial Packaging Solutions: Balancing Cost, Time and Quality
Explore critical factors in the packaging design process that can deliver the best possible outcome for your clinical study and, ultimately, the patient.
eBook
Clinical Trial Packaging: Smart Choices Can Trim Timelines
Get important insights to help guide the development of your packaging strategy to streamline study timelines and increase the likelihood of success.
eBook
Cold Chain Industry Trends
Take a look at the importance of a robust supply chain and get planning recommendations for pharma companies scaling up to global vaccine trials.
eBook
Cold Chain Shipping Considerations
Overview cold chain shipping considerations, examine different temperature controlled packaging options and learn the advantages/disadvantages of various coolants.
eBook
Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
Download the eBook to learn about the different types of considerations when shipping biologics.
eBook
Defense in Depth – Off-Site Storage of Biological Specimens and Biopharmaceuticals for Risk Mitigation
The management of risk is part of all business operations, but to commercial biobanks, clinical research institutes, biotech, and pharmaceutical companies, risk mitigation is a critical element of day-to-day operations. The costly nature of irreplaceable samples/cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (Bio-API) dictates planning for the full continuum of risk. The best solution is frequently off-site storage.
eBook
Evaluating and Qualifying Temperature Managed Shippers
Discover the top 5 questions to ask when evaluating shipper options and the many benefits of return and re-use programs. Plus, get the results of a case study and pilot program.
eBook
Importer of Record Frequently Asked Questions
Get answers to frequently asked Importer of Record questions, a checklist of roles and responsibilities and a glossary of terms.
eBook
Reasons for Building an Approved Phrase Library
Learn how an approved phrase library can reduce label timelines, improve quality, and assure regulatory compliance.
eBook
Safely Transporting Medicines to Patient: De-Risking the Supply Chain
Download this eBook to view the survey results and accompanying analysis about what it means to pick the best pharmaceutical logistics partner.
eBook
Smooth Transition: What Specialty Drug Manufacturers Should Know About Bridging the Gap from Clinical-to-Commercial Packaging
As a steady stream of specialty drugs enter the marketplace, pharmaceutical companies are seeking new supply chain solutions to ensure that an uninterrupted supply of these breakthrough treatments reach patients. One solution for the challenges of packaging specialty products is low- or small volume commercial packaging.
eBook
The Challenge of Keeping Cool: End-to-End Temperature Management for the Clinical Supply Chain
Learn about managing the storage and transportation environment, what the regulatory definitions are, and planning for end-to-end temperature management.
eBook
Thinking Outside the Freezer: DNA and RNA Storage
Download this ebook to learn alternative solutions for DNA and RNA storage options.
eBook
Top 5 Questions Asked About Pre-Filled Syringes
Asking key questions of your prospective supplier will help you make a better selection and design a better solution. Find out what they are and why they're important.
eBook
Clinical Trial Packaging: Innovative, Flexible and Time-Sensitive Solutions
Clinical trial packaging solutions can be as diverse as the medications they protect. Learn how our clinical study sponsors were able to implement a packaging design that scaled through all phases of the trial while reducing time and waste.
eBook
Total Transportation Management
The transportation of life science shipments has become increasingly more complex. Learn how to overcome challenges and avoid the high cost of failure.
eBook
Using an Approved Phrase Library
Find out how to avoid delays in translating and approving clinical labels that can prevent clinical trials from starting on time and threaten to derail development timelines.
Case study
Managing Clinical Ancillary Supplies at a Global Scale
Follow a biopharmaceutical company entering a Phase III trial that included 45 countries and an enrollment target of 4,000 patients in a randomized, double-blind, placebo-controlled study.
Case study
Automation Slashes Turnaround Time for Clinical Trial Labeling
Find out how a radical reduction in the time it takes to produce clinical trial labels was realized for a multinational trial.
Case study
Clinical Packaging: Process Overhaul Cuts Cycle time by 55%
Learn how lean manufacturing techniques, label modifications and operational improvements helped support clinical trials of a blockbuster oncology drug.
Case study
Clinical Supply Global Optimization
Read this case study to gain insight into how to smooth the execution of your distribution strategy and ensure all your patients have the right medication on time.
Case study
Clinical Supply Optimization: Mid-Sized Pharma Embraces Forecasting
With no solid demand planning due to understaffing, a mid-size pharmaceutical company ran into serious trouble with stockouts and incorrect drug shipments that threatened to jeopardize its clinical trial program. Learn how Thermo Fisher quickly assessed the issue and reconfigured the interactive response technology to start producing accurate forecasting statistics, thereby saving the program.
Case study
Cold Chain Reusable Shipper Reduces Risk and Waste
Learn how a multinational pharmaceutical company found itself face-to-face with a sustainability challenge and turned to a new shipping solution, reusable shippers, to help them reduce their waste and carbon footprint.
Case study
Cost Savings and Speed: The Untapped Value of a Single-Source Solution
Learn how one small company took advantage of our Quick to Care™ solution to streamline its drug development and expedite the path of molecule to commercial drug product.
Case study
Delivering Clinical Trial Medications Direct-to-Patient
Download this case study to learn how Thermo Fisher Scientific was able to provide Direct-to-Patient services to meet a critical need.
Case study
Development of Qualified Cold Chain Solution for Vaccine Transport to Uganda
A government contractor required the development of a repeatable and effective pack out which could maintain steady temperature of 2°-8° C (35°-46° F) during transit for the transportation of vaccines (varying payloads) which were shipped to Uganda as part of a study. This was quite challenging given the logistical challenges that exist given the remoteness in access.
Case study
Direct to Representative Sample Distribution Services
Learn how we helped a manufacturing company design an efficient sample distribution program to minimize product loss, while ensuring full compliance with industry regulations.
Case study
Expedited Import of Zika Virus Test Kits Enable Vital Research
Given the rapid and widespread outbreak of this virus, researchers were urgently working towards a solution. In a significant breakthrough, a European-based manufacturer had successfully developed a test kit that enabled serological detection of the Zika virus. Getting these kits into the labs of the United States researchers became a critical priority.
Case study
Global Ultra-Cold Clinical Trial Logistics
The Challenge: A new United States-based biopharma working on its first cell therapy-based treatment had expanded the scope of their trial and extended its patient pool to include a patient in Beijing, China.
Case study
How a global network enabled distribution of an oncology drug to 60,000 patients in 35 countries every month
Angie will never forget the day she got a call from a client with a packaging and logistics challenge of global proportions. They needed help figuring out how to get an oncology drug labeled for 60,000 patients in 35 countries every month. And they needed that solution to fit in a four-week cycle. Read the case study to learn how the team reduced the cycle time in half.
Case study
How an emergency IND was able to reach a patient in under 12 hours
It’s Saturday. A six-day-old baby needs emergency medication. You need a team that’s prepared for situations like this to turn two and a half days of logistics into just 12 hours. Download this case study to learn how Holli and her team made it happen.
Case study
How overcoming barriers ensured on-time delivery of a life-changing medication
A new drug made in Canada. Shipped to Mexico. Now needed in Brazil. If the client didn’t make this launch, the region would have lost all access to this medication. Download this case study and see how one team’s experience cracked the code.
Case study
Packaging Design Provides Time and Cost-Efficiencies for a Growing Biopharma Company
Learn more about the process of designing a blistering package project that delivered an optimal, cost-effective solution for a growing biopharma.
Case study
Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product
Learn how our stepwise approach to Quality by Design (QbD) became integral to the success of the Amylyx Pharmaceuticals AMX-0035 campaign.
Brochure
Global clinical supply solutions for every trial delivering the right drug to the right patient, on-time, in-full, and without compromise
In the highly competitive, new drug development market, biopharma companies face a myriad of challenges—from balancing cost, time, and quality, to delivering the best possible outcome for their...
Brochure
Pharma Services EMEA network, integrated network from molecule to medicine
Our objective is to help speed your molecule through early phase trials and prepare you for commercial success, faster. In this brochure, find out more about our dedication and...
Case study
Not Just A Vendor, But Part Of The Team
Learn how the Clinical Label Services team helped an emerging biotechnology company reduce cycle times and ease the burden of lengthy clinical timelines and unhappy sites.
Case study
Accessing patient populations in remote locations presents challenges for ambitious new trial
A top major pharmaceutical company needed guidance on how to run an ambitious clinical trial in the Asia Pacific region involving 10+ countries, 74+ sites with 400+ shipments across the region.
Case study
An alternative logistics approach realizes cost and performance efficiencies in Asia Pacific
A top major pharmaceutical company with research priorities aligned to significant global health needs had a high number of studies in progress in the Asia Pacific region.
Case study
Clinical ancillary management – tackling the complexities of a global diabetes trial
A large manufacturer needed support for their global diabetes trials. The scope of a single trial often included as many as 1,500 to 2,000 patients in 15 to 20 countries across all geographic regions (US, EU, Asia, Middle East).
Case study
Clinical ancillary supply management – streamlining ancillary supplies and the investigator experience
A top 25 global pharmaceutical company came to Thermo Fisher Scientific requesting support for a complex global program encompassing 15 studies across 53 countries over 1,000 sites and for over 12,000 patients.
Case study
Clinical supply optimization – clarifying the relative risk of change
The clinical team at this top ten pharmaceutical company struggled with the delicate balancing act between controlling the costs of a major oncology trial and making strategic investments that would pay off in the long term.
Case study
Clinical supply optimization – digging for the true cost of clinical supply
Pharmaceuticals are a small part of this company’s overall business and its team was relatively new to clinical supplies.
Case study
Clinical supply optimization – enhanced service model saves trial sponsor time on supplies
The vice president of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager.
Case study
Clinical supply optimization – investigator supported studies streamlined
The key to a successful program of investigator supported studies is maintaining productive relationships with the physicians at the clinical sites.
Case study
Early Licensure of a Breakthrough Cancer Drug Gives Hope to Patients
This compelling case study outlines how a multinational pharmaceutical company worked with a cross-functional Fisher Clinical ServicesSM team to deliver clinical supplies to treat an aggressive form of skin cancer, Merkel cell carcinoma.
Case study
Flexibility Enables Managing Large Leaflet on Automatic Packaging Line
A large multinational pharmaceutical company asked the Thermo Fisher Scientific Ferentino site to fix an issue that resulted from a change request to increase the size of the product information leaflets. These leaflets were important and required for regulatory and marketing reasons. Download the case study to learn more.
Case study
High Precision Syringe Labeling
Discover how high precision labeling helped a customer who had to blind their syringe against commercial drug product by applying a label containing a dosing scale to syringes of varying lengths.
Case study
How to Select the Best Courier Around the Globe
Get an in-depth look at the clinical trial challenges faced by a world leader in biotechnology and the actions taken to realize surprising results.
Case study
How a Best-Practice Strategy for Sourcing Ancillary Materials Reduced Risk, Spending and Workload in a Global Diabetes Trial
Learn how a sound strategy and solid execution plan enabled this company to overcome the challenges they faced to ensure that their patients received the ancillary products they needed.
Case study
The Critical Importance of Comparator Temperature Excursion Management: A Robust Quality Assurance Process
Learn how Thermo Fisher helped two clients to overcome comparator sourcing challenges and avoid costly delays in their clinical trials.
Case study
Total Transportation Management Saves Company $10.2M
Learn how a multinational pharmaceutical company optimized transportation costs, maximized on-time, in-full delivery to all global locations and delivered enhanced site satisfaction.
Video
How Embracing Flexibility Creates Success for All
Learn how Whitney took on the challenge of creating more flexibility within existing rigid processes to better meet the needs of her client. Together, they came up with a solution to optimize critical paths forward to expedite getting life-saving therapies to the patients who need them.
Case study
Clinical supply optimization – mid-size pharma rejects bulk, avoids shortage
Many companies developing biosimilars are not confident in their own capacity to forecast supply needs and manage them on an ongoing basis.
Case study
Expert handling of high-risk clinical trial product in Mexico
A multi-national sponsor needed a reliable provider with a wealth of expertise in delivering highly complex products from point of origin to patients at investigator sites, on time and in perfect condition.
Case study
Free trade area attracts zone sponsors to India
A top major pharmaceutical company needed guidance on how to run an ambitious clinical trial in the Asia Pacific region involving 10+ countries, 74+ sites with 400+ shipments across the region.
Brochure
Clinical Trial Supply Solutions
Learn how our global team can meet the needs of every trial regardless of size, phase or therapeutic area.
Brochure
Continuous Monitoring Solutions for Cold Chain Logistics
Download this fact sheet to learn about our continuous monitoring solutions for cryogenic shipments.
Brochure
Transportation Solutions for Cell and Gene Therapy Supply Chains
Learn key considerations for evaluating transportation partners for your cell and gene therapy supply chain.
Presentation
How to pick the right CDMO for latephase clinical trials
For pharmaceutical companies without their own facilities, choosing the right partner for late phase clinical trials and commercial production is a critical consideration in developing parenteral products.
Case study
How clinical trial design impacts the supply chain
A pharmaceutical manufacturer established a head-to-head study comparing the safety and efficacy of Product A and Product B (the competitor’s product) for diabetic peripheral neuropathic pain (DPNP).
Case study
Supplier collaboration delivers innovative solution for trial sponsor
In clinical trials using interactive response technology (IRT) drug dispensation is normally triggered after site activation or patient screening.
Case study
Clinical Ancillary Management, Solutions for Oncology Studies
Learn how to eliminate the need to determine unnecessary site-specific supplies and save months of work for all parties while increasing flexibility in the supply chain.
Whitepaper
Comparator local sourcing strategies: Leveraging advantages and avoiding common pitfalls for clinical trials
This whitepaper will focus on local sourcing. Local sourcing is the purchase of a commercial drug within a single country for use in that same country.
Whitepaper
Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas
"Faster and better" has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before.
Whitepaper
How to build a robust packaging strategy for rapid commercialization
When initial clinical trial results for a new drug show promise, the focus begins to shift to commercialization and planning for a pharmaceutical packaging strategy.
Whitepaper
Impact of Incorrect Forecasts on New Product Launches
Pharmaceutical companies around the world are under tremendous pressure – from regulators, legislators, payers, and patients – to reduce the cost of drugs.
Whitepaper
Who’s Watching Your Supply Chain? Strategies for Mitigating Risk in Clinical Trials
With the ever increasing costs of clinical trials and the advantages of being first-to-market, it’s time to take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within your budget.
Webinar
Accelerating innovative therapies to patients in a post pandemic world
Learn from industry experts and esteemed guests on hot topics including:
From research to clinic: the path to success for cell therapy companies
Evaluating options for outsourcing discovery research
Whitepaper
Comparator local sourcing for clinical trials: Balancing opportunities and challenges
There are several reasons why the market for comparators is growing. For one thing, more clinical trials are being conducted today than ever before and more of those trials are using active comparators.
Whitepaper
Bulletproof your supply chain: Hope for the best, prepare for the worst
Hope is not a strategy in drug manufacturing. You need a contingency plan to protect your company and your customers if the worst-case scenario occurs.
Whitepaper
Opportunities and challenges for clinical research in China
Today China is a dominant presence in the clinical trial arena and one of the most desirable
Whitepaper
What clinical teams should know about changing trial logistics and how they will affect development
When it comes to clinical supplies, the journey is every bit as important as the destination. And these days, the journey of clinical supplies to investigator sites is becoming costlier and more complex, much like the global trials for which the materials are bound.
Fact sheet
Qualified Person (QP) Services
Learn how our team of QPs bring extensive experience across a wide range of dosage forms including aerosols, biologicals, creams, liquids, ointments, solids, sterile products and novel drug delivery systems.
Infographic
Depot to Patient Service Overview
Download this infographic to learn more about the Depot-to-Patient service.
Infographic
10 Ways to Derail a Clinical Trial
Learn important factors to consider when developing your clinical supply planning strategy to avoid derailing your clinical trial.
Infographic
5 Common Clinical Supply Chain Speedbumps and How the Right Partner Can Help Avoid Them
Download this infographic to learn about 5 common issues, and why it is important to select the right partner.
Whitepaper
EU Clinical Trial Regulation 2022: Understanding the impact on clinical research in Europe
Learn more about key changes introduced by the EU Clinical Trial Regulation (CTR) 2022 regulation, with guidance for managing anticipated challenges.
Article
Ancillary supplies clinical trial must haves that require early planning
Learn why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.
Article
Debunking Myths and Misconceptions About Softgels
Explore seven myths about softgel formulation for prescription drugs and why this dosage form is more viable than formulators may assume.
Infographic
Direct to Patient Pharmacy Services
Download this infographic to learn more about the supply chain options for decentralized clinical trials.
Infographic
5 Big Common Missteps in Comparator Sourcing
Do you know the 5 big common missteps in comparator sourcing? Download our infographic to find out.
Infographic
10 Steps That Risk Failure in the Temperature Controlled Clinical Supply Chain
Download this infographic to understand the questions you should be asking to be better positioned to ensure zero excursions and maximum product integrity.
Infographic
Maintaining the Cold Chain in European Distribution
Learn top tips for maintaining cold chain integrity across the European supply chain with the growth of biologics and vaccines in the biopharma sector.
Infographic
Made with proof & purpose
Made with proof & purpose Your molecule has the potential to change lives and shape the future.
Whitepaper
Comparator local sourcing strategies: Leveraging advantages and avoiding common pitfalls for clinical trials
This whitepaper will focus on local sourcing. Local sourcing is the purchase of a commercial drug within a single country for use in that same country.
Whitepaper
Considerations for your first clinical trial
Learn why sponsors should consider partnering with an organization with demonstrated expertise, ability to work across geographies and cultures, a keen understanding of local and international requirements, and that offer models for support at multiple levels.
Whitepaper
Considering the clinical supply chain in vaccine trials: Special handling required
Vaccines are one of the most useful and cost-effective means of reducing illness and death from infectious diseases. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
Whitepaper
Clinical trial simulation: Advanced modeling techniques enable data-driven supply chain planning
The logistical challenges of matching drug supply to research needs in clinical trials have increased by an order of magnitude in recent years.
Whitepaper
Clinical Trial Supply Solutions
Whether you need primary or secondary packaging of your clinical drug, storage, distribution, logistics, cold chain management, or comparator or ancillary sourcing, our global team can meet the needs of every trial regardless of size, phase or therapeutic area.
Whitepaper
Enabling fast and appropriate drug product supply for phase 1 clinical trials
Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs.
Whitepaper
Focus on drug delivery What clinical teams should know about the benefits of auto-injectors
More drugs are being delivered by injection than ever before, fueled by a steady stream of biological products emerging from research pipelines.
Whitepaper
How explosive growth in biosimilars presents new challenges in the clinical trial supply chain
With patent protection for many innovator biological drugs expiring within the next few years, the early 21st century may well be remembered as the dawn of the Biosimilar Era, and for good reason.
Whitepaper
Managing supply logistics in an expanding clinical trial universe: New challenges for global clinical trials
Today, half of all clinical trials are conducted offshore and in more developing countries than ever before, profoundly increasing the complexity of supply chain logistics.
Whitepaper
What every clinical team should consider before developing the next protocol: Putting volunteers first
Learn why even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience.
Whitepaper
Ukraine & Russia: Opportunities and Challenges for Clinical Research
Discover why Ukraine and Russia are among the top choices for clinical development.
Blog post
The Four Stages of Equipment Qualification
As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use.
Blog post
Top Tips on How to Manage Clinical Label Translation and Regulatory Requirements
Wouldn’t it be nice to find a way to stay on top of label translation and regulatory requirements for every country included in your clinical trial?
Blog post
Introducing an Expanded Packaging Service for Specialty Products
Developing a specialty drug for a complex or rare disease is an achievement worthy of celebration.
Blog post
Is Your Supply Chain Bulletproof?
Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.
Blog post
Myths & Facts about Ancillaries
It’s a fact that ancillary supplies are frequently perceived as less important than study drug.
Blog post
Is it Time to Start Thinking about Packaging?
If this headline caught your eye, it may be because you’ve received promising pre-clinical results (Congratulations!) and you’re starting to think about planning your next steps.
Blog post
Regulatory landscape in Europe: Key advice for meeting post-Brexit Qualified Person requirements
The United Kingdom’s (UK) departure from the European Union (EU) has added a layer of complexity to the clinical trial supply chain in Europe above and beyond COVID-related disruptions.
Blog post
Time to embrace electronic labels? Potential labeling solutions under the new EU Clinical Trial Regulation
The new EU Clinical Trial Regulation (CTR) is intended to simplify clinical trial administration and create a more welcoming climate for pharmaceutical companies that operate in Europe.
Blog post
How Decentralized Clinical Trials Enhance Patient-Centricity in the Age of COVID-19
As COVID-19 continues to change how we do business in the biopharmaceutical industry, it’s important to not lose sight of why we do what we do: improving and saving patient lives.
Fact sheet
Comparator and Co-Medication Sourcing Services
Learn how our Comparator Center of Excellence Team can assist you with developing the most cost effective strategy for securing the medications locally, regionally, globally or a combination of all the above.
Case study
Clinical supply optimization enhanced services – process improvement reduces study startup phase by 40 percent and drives improved supply chain execution
Clinical supply optimization enhanced services – process improvement reduces study startup phase by 40 percent and drives improved supply chain
Clinical Supply Optimization Enhanced Services – process improvement reduces study startup phase by 40 percent and drives improved supply chain execution
Read this case study to learn how with proper controls, operating procedures, and training in place, the Clinical Supply Optimization team adopted the new duties in addition to planning, forecasting and inventory management tasks.
Case Study
Creative packaging solution yields significant savings for an emerging BioPharma company
A small, emerging biopharma company developing an oncology Investigational Medicinal Product (IMP) had been working with Fisher Clinical Services to blister-pack capsules in a 12-pack strip. Download this case study to learn more.
Fact sheet
Cold Chain Management & Mindset
Learn how our integrated processes, the latest technology, and our zero temperature excursion mindset mitigates the risk of temperature excursion throughout the end-to-end supply chain.
Fact sheet
Clinical Ancillary Management
Learn how a highly organized and rigorously managed process can increase study efficiency and minimize the risk of your patient missing a dose.
Fact sheet
Clinical Supply Optimization Services
Learn how Clinical Supply Optimization Services can optimize and streamline the clinical supply chain from early strategy development through packaging, distribution, site inventory management, and returns/destruction.
Fact sheet
ATLAS (Alternative Translation and Label Approval System)
Learn about our proprietary, web-based Alternative Translation and Label Approval System (ATLASSM)—a validated, clinical label translation management service that automates and optimizes multi-lingual label text development.
Fact sheet
Global Label Services
Learn how our Global Label Services team leverages purpose built, integrated facilities, a global presence and the information systems and flexibility to allow unparalleled visibility and control while offering time-saving, seamless transition opportunities throughout the clinical supply chain.
Fact sheet
Global Logistics Help Desk
Learn how data intelligence is used to select the best courier for each country, helping our Sponsors to realize cost and performance efficiencies across the supply chain while mitigating risk and adhering to clinical trial timelines.
Fact sheet
Direct-to-Patient Services
Download this fact sheet to learn about end-to-end solutions that connect your treatments directly with your patients.
Fact sheet
Investigator Initiated Trial (IIT) Service for Pharma Companies
Learn how our IIT service offers comprehensive oversight and management of all clinical supply activities for a portfolio of Investigator Initiated Trials.
Fact sheet
Investigator Initiated Trial (IIT) Service for Institutions
Learn how our IIT service offers comprehensive oversight and management of all clinical supply activities for a portfolio of Investigator Initiated Trials.
Fact sheet
Sample Fulfillment & Distribution Overview
Learn more about our full range of services in support of your Direct-to-Representative and Direct-to-Practitioner sampling programs.
Ahmedabad, IN (Special Economic Zone)
Strategically located in one of India's Special Economic Zones (SEZ), our ability to act as Importer of Record (IOR) for import into the Free Trade Zone and our ability to procure a regulatory manufacturing permit for 3rd parties make clinical trial supply conduct simpler and safer for sponsors worldwide.
Fact sheet
Specialty Courier Services Overview
Learn more about our ability to design an optimal specialty courier solution that includes everything from recommended shippers to facilitating import/export clearance.
Fact sheet
Pre-Filled Syringe Assembly & Labeling
Learn about our fully automated, continuous process from syringe assembly to label application to electronic verification of label text.
Fact sheet
Reusable Shipper Program
Learn how a reusable shipper program can bring multiple benefits for all stakeholders and further increases the quality across the supply chain.
Fact sheet
Total Transportation Management for the Life Science Industry
Learn how our Total Transportation Management service helps sponsors manage the complex supply chain processes required to move manufacturing API, IMP, comparator medication and ancillaries through to commercial goods, both internationally and within country of destination.
Interview
Ensure a timely arrival
Stalled deliveries of clinical supplies to global investigator sites have the potential to derail trials and put study patients at risk. Clinical Trial Insight talks to Ian Hunter, commercial director of logistics at Fisher Clinical Services, about the company’s strategy for minimizing delays to ensure clinical supplies reach the sites and patients who need them on time.