Friday, September 30

CRO Diaries: Basic Checks To Conduct When Choosing A Bioanalytical CRO

The drug discovery and development process is a complex endeavor. Hence, the entire drug development life cycle must be highly optimized to save resources and time. Over the years, bioanalytical CROs have emerged as a vital partner for bridging the gap between drug discovery and product launch by handling all new drug development burdens. Data research, preclinical and clinical studies, project management, and post-approval support are some basic activities bioanalytical labs cover for sponsors and clients.

Bioanalytical CROs must add value to the drug development project. While looking for a partner CRO, sponsors must consider laboratories that can deliver comprehensive bioanalytical services while supporting the research throughout the project. Hence, choosing a partner laboratory is a complex yet critical process, and sponsors must cautiously evaluate them. The current article provides some basic checks for sponsors to conduct while choosing a bioanalytical cro.

Bioanalytical services

The first basic criteria for choosing a bioanalytical CRO is to evaluate the bioanalytical services offered by the partner laboratory. Clinical trials are a multi-facet endeavor. Therefore, the partner laboratory must be equipped to cover all aspects of clinical trials. Some essential services a bioanalytical CRO must offer include site selection and activation, regulatory affairs, monitoring, site management, logistics, data management, biostatistics, pharmacovigilance, and medical writing.

Experience

An ideal CRO will not only have experience in managing clinical studies but will also have an experienced staff skilled in clinical trial management. Verifying the experience is another crucial consideration while selecting a partner CRO. Sponsors should identify the number of years a CRO has been in the business, the number and phases of clinical trials managed, countries in which research was conducted, and expertise in therapeutic areas. 

Knowledge of the disease of interest

Knowledge about the disease of interest is also  vital  in the selection process. A CRO with prior expertise in the disease of interest can make a massive difference while performing clinical trials. For example, data managers, researchers, and scientists with expertise in cancer research will be more efficient in guiding sponsors to design, monitor, and manage cancer studies.

Access to patients

CROs with access to the patient population is crucial for  accelerating  clinical studies. Sponsors must evaluate whether CRO can facilitate access to high enrollment sites. Due to their constant interaction with investigators and hospitals, CROs can recommend sponsors some potential enrollment sites for recruiting patients with a specific disease. Hence, sponsors must choose a bioanalytical CRO that can provide access to patients and save the time required for searching patient enrollment sites.

Quality management

High-quality data and compliance are the core of a successful clinical trial. Hence, their importance cannot be overemphasized. An efficient bioanalytical CRO will have a quality management system that meets all requirements of Good Clinical Practice and international quality standards.

Before choosing a bioanalytical lab, sponsors must conduct on-site vendor audits to authenticate quality control practices. Such authentications can help sponsors understand  CRO’s management, staff expertise, quality compliance, and efficiency in handling diverse study protocols.

Not to mention, geographical coverage, CRO responsiveness, staff continuity and proficiency, technology, pricing, and financial stability are some more checkpoints sponsors must evaluate before choosing a bioanalytical CRO.

Follow nbaim.org for more such useful content.

Leave a Reply

Your email address will not be published.