Medicine and drug development are undergoing change. The role of Contract Research Organizations (CRO) is ever-expanding in the current scenario. The shift to CROs has risen due to several factors.
Business requirements, like cost incentives and downsizing, have played a big role in this shift. Another major factor is the growth of translational medicine. This is taking medical research and drug development from a compound-based to an evidence-based drug discovery model.
Evidence-based discovery encourages preclinical cro and bringing the resulting safety and efficacy to a clinical setting. The role of preclinical experimentation has increased greatly. It often involves complex experimentation and procedures to check the efficacy and safety of a drug. These include, but are not limited to PK/PD analysis, TK and tox studies, DMPK studies, etc.
Banking On Skills Of A Preclinical CRO
The increased complexity and requirements make the use of preclinical research services necessary. Preclinical development is very arduous. The New Chemical Entity (NCE) or drug candidate will undergo several experiments to establish its safety and efficacy. Results obtained in this stage will greatly affect drug design and development.
Several methods find use during preclinical development. A CRO may use in vitro, in vivo, and ex vivo testing during preclinical experimentations to ascertain drug characteristics. These, coupled with other studies can lead to establishing important drug parameters. For example, aspects like drug formulation, bioavailability, safe dosage, drug administration path, and others become clear as the preclinical study progresses.
A lot of drug candidates fail in preclinical development. The natural reason for such a result could be the drug not being successful in efficacy or safety requirements. Another big problem for the Preclinical CRO to handle in this stage are regulatory requirements. Unforeseen pitfalls created by regulatory requirements can derail drug development.
Handling Regulatory Aspects
CROs don’t just have to handle the scientific requirements of development, but also regulatory aspects. Amongst other requirements, these include conducting research under GLP (Good Laboratory Practices) requirements. Being GLP-compliant is a requirement for experimentation before a drug can be moved to clinical trials or human use.
GLP experiments, however, can be cost- and time-intensive. The CRO has to decide what parts of the development process can be achieved through non-GLP studies. Striking a balance between these requirements allows a preclinical CRO to fulfill requirements while saving time and money.
Another aspect is maintaining the credibility and integrity of the obtained data. While this is necessary for GLP, it serves well for non-GLP studies as well. Credible data can find use in several aspects of drug development and guide future attempts and progress.
A CRO is a multi-dimensional business going beyond the laboratory, though of course, the lab remains the core area. The drug development journey requires a range of professionals across disciplines working together.
Scientists, medical personnel, administrators, marketing experts, regulatory liaisons, technical staff, and several others are involved. And that’s just for preclinical study. CROs often have to find ways to establish and manage communication between all these stakeholders. Of course, this has to be done while maintaining the goals of the CRO and the sponsor.