Know The Basics: How Do Bioanalytical CROs Support Preclinical And Clinical Research

April 11, 2022
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A contract research organization (CRO) provides bioanalytical support to biotechnology, pharmaceutical, and medical device companies. These research support can range from early drug discovery studies to clinical trials, commercialization, and marketing services.. Bioanalytical services CROs provide expertise to initiate and complete preclinical and clinical research studies, negating the need for sponsors to hire in-house professionals. Within drug discovery and development, sponsors partner with a CRO on a project-to-project or a contractual basis

 

There are different bioanalytical CROs, with testing services ranging from discovery, preclinical, clinical, and laboratory services. CROs are commonly grouped based on the services they provide for sponsors in drug development. But what is drug discovery and development, and what role do CROs play in it? The following article outlines  the basics of bioanalytical CRO in preclinical and clinical research.

 

Bioanalytical CROs in preclinical and clinical research

 

The primary duties of a bioanalytical services CRO are to plan, set up, execute and manage contracted preclinical and clinical research. The drug discovery and development phase can be divided into three stages, drug discovery and preclinical stage, clinical stage, and post-approval stage. A CRO can assist sponsors in each of these drug development phases.. However, managing and supervising medical tests and data collection are a  crucial aspect of preclinical and clinical research. Besides, bioanalytical CROs have proven expertise in adhering to GLP and GCP compliances, as they are a central point for connecting the sponsors and companies with different stakeholders.

 

In preclinical research, bioanalytical CRO offers necessary R&D support to help advance drug compounds from animal testing to the clinical trial phase. Preclinical research is mandatory to assess the safety and efficacy of a drug compound in animals before applying for IND submissions. A successful IND completion is a primary step towards the clinical phase. If preclinical studies are not conducted and designed appropriately, regulatory bodies may decline the IND application. Besides, due to suboptimal testing and adverse effects, many drug products are rejected in the preclinical phase. Hence, bioanalytical CROs with relevant expertise are crucial during preclinical research.

 

Once a potential drug candidate is finalized through preclinical testing, sponsors move on to the clinical trial phase to assess safety and efficacy in human subjects. The clinical trial phase is conducted in four phases, Phases I, II, III, and IV. Although the clinical trial phase follows these phases, each trial phase is independent of itself, and a drug compound may be rejected at any point of a clinical trial.

 

In the clinical research phase, a bioanalytical laboratory first plans and develops a clinical trial and then executes the clinical trial according to regulatory guidelines and compliance. Drug development companies have several drug products in the pipeline, and hence they outsource a bulk of these studies to save time and resources for more intensive in-house research. Besides, due to exposure to a wide range of drug development projects, CROs are adequately equipped to conduct clinical trials while anticipating and avoiding potential roadblocks.

 

Hence, bioanalytical services CRO are increasingly becoming the backbone of a successful drug discovery and development program.

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