Phasing Out Inefficiency
Struggling with process research and development? Find yourself a CRO that knows what it’s doing.
Simon Tyler | | Opinion
Drug developers are all too familiar with the numerous challenges faced at each phase of the clinical trial process. Solid chemical process research and development (PR&D) plays a crucial role in ensuring that the required amount of drug can be manufactured to the required quality in an economically and environmentally sustainable manner. Knowing just how important it is to get PR&D right across all phases, time and resource-squeezed organizations will often outsource projects to contract research organizations (CROs) – tapping into their additional expertise and facilities.
Though the relative importance of speed, quality and cost will vary across the drug development timeline for a new chemical entity (NCE), one important factor remains constant: risk management. When working with a CRO, potential challenges can be governed using effective communication. It is critical that both parties remain on the same page. The CRO should take the time to fully explore the broader contexts and objectives of a project, be able to grasp the chemical and technical challenges in detail, and be asking any questions that will allow it to create a customized solution.
Lines of communication should be kept open throughout the various stages and phases of a PR&D project; no doubt a customer’s concerns will be dynamic and alter according to the uncertainties and risk associated with getting a molecule to market. Organizations looking to outsource PR&D need to know that their CROs are there to listen and support them through every challenge that may crop up across all drug development phases. Likewise, one must give CROs the opportunity to ask questions; they can’t manage expectations effectively if they are kept in the dark about certain aspects of a project.
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