Successful supply of clinical materials is key to assure that clinical studies are conducted as planned at the correct time with the correct dose and correct amount of materials. However, complexity impacts the timeline, process and cost of turning a molecule into a drug for clinical trials.
- Process
The process of complex drug discovery and development is long and expensive as many biological targets must be considered for every new medicine eventually approved for clinical use. Furthermore, new research tools may be needed to investigate each new target.
- Timeline
There are typically several chemical steps needed to make complex material for clinical trials. Even if one step has poor yield it can cause a huge setback in terms of time for pharmaceutical organizations. There never seems to be enough time, especially when it comes to developing an NCE.
True collaboration with a CDMO (Contract Development and Manufacturing Organization), CRO (Clinical Research Organization) or CMO (Contract Manufacturing Organization) can destress the process of preparing a drug for clinical trials.
- Cost
Complex studies present unique cost considerations. With such a large financial burden, many trials are underfunded, and may not have any reasonable opportunity to generate a positive outcome even if protocols are amended, at additional cost. Underfunded trials are by definition more likely to miss the enrollment needed to demonstrate statistical significance at a predefined level of efficacy.
Studies that contribute to solving any of the many scientific and operational issues involved in the clinical development process can improve the efficiency of the process. An awareness of these issues allows the early implementation of measures to increase the opportunity for success.
Working with CDMOs (Contract Development and Manufacturing Organizations) which function as API suppliers or API manufacturers allows partnering pharmaceutical companies to benefit from a long-term collaboration with an experienced team offering specific skills, equipment and technical resources that are not available internally, resulting in a robust clinical API supply chain, reduced risks and optimized costs for integrated API clinical trial material development and manufacturing services.