Selecting a reliable CRO is critical for the success of a drug discovery and development process. By definition, the drug discovery process identifies prospective therapeutic molecules having the potential to effectively and safely treat disease and medical conditions. At any given moment, there are hundreds of potential molecules in the early drug discovery pipeline. Hence, it is demanding to evaluate each compound and ensure its smooth transition through preclinical and clinical studies. Most companies today choose to outsource bioanalytical studies to contract research organizations. However, finding the right CRO for drug discovery processes can be challenging. Hence, we share crucial considerations for choosing the right CRO.
CRO selection for drug discovery and development
The following are vital benchmarks sponsors must consider while choosing a CRO for drug discovery and development processes.
The first step is to identify services a CRO provides during preclinical and clinical research. A drug discovery and development process involves several tasks, and therefore a contract laboratory must be equipped to perform them as soon as possible. Services an ideal CRO must offer include site selection, regulatory compliances, site management, monitoring, logistics, data management, pharmacovigilance, medical writing, biostatistics, and project management.
Another crucial aspect to consider is the experience of the contract laboratory. Sponsors must identify their years of experience, the number of trials managed, the countries worked in, and expertise in specific therapeutic fields. Besides, the CRO should not only have experience in providing bioanalytical services but must also have experienced staff with in-depth knowledge of clinical trial management.
Knowledge of the disease
A well-knowledgeable CRO staff can make a huge difference in completing clinical trials. For example, for sponsors conducting cancer research, a CRO with expertise in cancer research studies will be an added benefit for the sponsors. The CRO can guide with oncology protocol, tumor assessments, study endpoints, and monitoring strategy. Hence, knowing the desired therapeutic niches is a valuable characteristic.
Access to study patients
One of the most valuable contributions a CRO can offer is quick access to sites with a higher potential for enrollment. An ideal CRO can contact investigators and hospitals and recommend study sites for recruiting patients for those specific fields of interest. Hence, evaluating whether CROs have connections with hospitals and a strong recruitment profile is vital before choosing a partner CRO. Such early insights will help sponsors save the time needed for identifying and selecting study sites.
Clinical trials are highly complex processes generating a large quantity of study data. Hence, technology is essential for efficient study data management and streamlining of clinical studies. Sponsors must evaluate the tools CROs use in managing clinical trials. Sponsors must identify what kind of electronic Trial Master File and Electronic Data Capture systems a CRO uses and whether good results are generated using these systems. Besides, an ideal CRO must perform bioanalysis using modern methods, such as MesoScale Discovery multiplex assays. MSD mesoscale assays are multiplexing systems that detect multiple analytes in a single sample volume. Thus, sponsors must choose a CRO who has demonstrated expertise in using technologies such as MesoScale assays.