Find your right path to First-in-Human clinical trials, faster

Delays in reaching first-in-human (FIH) clinical trials most commonly stem from challenges in preclinical development, manufacturing readiness, and regulatory alignment. Incomplete or inconclusive toxicology, pharmacology, or IND-enabling studies often require repeat or supplemental work, extending timelines. Chemistry, Manufacturing, and Controls (CMC) issues—such as scale-up difficulties, formulation instability, analytical method validation gaps, or GMP batch failures—frequently slow readiness for clinical supply. Regulatory delays can arise from insufficiently prepared IND/CTA submissions, unresolved agency questions, or evolving guidance. Additionally, operational factors—including site selection challenges, protocol complexity, contract negotiations, and funding constraints—can further postpone study initiation. 

Drug developers should begin planning their clinical supply strategy as early as lead optimization or candidate selection, well before IND-enabling studies are complete. Early planning allows teams to align preclinical, CMC, regulatory, and clinical timelines, assess the scalability of their process, identify potential formulation and stability risks, and secure appropriate GMP manufacturing capacity. Proactive strategy development also supports realistic forecasting, analytical method development, tech transfer readiness, packaging and labeling considerations, and contingency planning for delays or batch failures. By integrating clinical supply planning into early development governance rather than treating it as a late-stage operational task, sponsors can significantly reduce the risk of timeline slips and costly rework as they approach first-in-human studies. Proactive cross-functional planning, early regulatory engagement, and robust CMC and preclinical strategies are key to mitigating these risks. 

Early-phase drug developers can move quickly toward clinical trials without creating future setbacks by taking a practical, risk-based approach that keeps the bigger picture in mind. That means building early processes and formulations with future scale-up in view, choosing manufacturing partners and platforms that can grow with the program, and using fit-for-purpose CMC strategies that are appropriate for first-in-human studies without cutting corners that may lead to rework later. By identifying the most critical risks early, aligning teams across functions, and engaging regulators proactively, companies can move fast in a smart way—reaching the clinic efficiently while setting themselves up for smoother progress in later phases.

To initiate a first-in-human (FIH) clinical trial, sponsors must submit an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in other regions, supported by three core categories of data:

1. Preclinical (Non-clinical) Data: These studies demonstrate that the drug is reasonably safe to test in humans. They typically include pharmacology studies showing proof of mechanism and target engagement, safety pharmacology, toxicology studies, etc. 
2. Chemistry, Manufacturing, and Controls (CMC): This data ensures the clinical material is consistently produced and suitable for human use. Components include drug substance and drug product manufacturing process descriptions, specifications and analytical methods (identity, purity, potency, impurities), stability data to support clinical shelf life, GMP compliance documentation, and container/closure and packaging information.
3. Clinical Protocol and Investigator Information: This section outlines how the study will be conducted safely, including detailed clinical protocol (objectives, design, dose escalation, stopping rules), rationale for starting dose and escalation scheme, investigator’s brochure summarizing all available data, investigator qualifications and site information, and informed consent documents.

Using an integrated CDMO and CRO can significantly streamline the path to first-in-human trials by reducing handoffs, aligning timelines, and improving cross-functional coordination. When development, manufacturing, and clinical execution are managed within a single organization, communication gaps are minimized, and CMC, non-clinical, and clinical activities can be planned in parallel rather than sequentially. This integration helps accelerate tech transfer, align regulatory documentation, and proactively address risks that might otherwise surface late in the process. It can also simplify vendor management, contracting, and oversight for sponsors. Overall, an integrated partner can improve speed, transparency, and accountability—helping programs reach first-in-human studies more efficiently and with lower operational risk.