A contract research organization (CRO) offers bioanalysis services to the pharmaceutical, medical device, and biotechnology industries. On the other hand, Pharmacokinetic CROs offer several functions and specialties concerning pharmacokinetic services. In a nutshell, bioanalytical CROs operate as contract agents to perform specialized tasks for their sponsors, with PK labs as an additional specialization. However, any data deduced and collected by a CRO lab, such as PK or ELISA lab, should be unbiased and adhere to regulatory requirements.
Earlier, CRO biotech laboratories began working with pharmaceutical and drug development companies by managing their toxicological and clinical trial initiative. Today, they conduct more complex tasks such as tissue engineering, pharmacokinetic studies, bioavailability and bioequivalence assessments, and biocompatibility of implants. The current article highlights the role of a pharmacokinetic CRO in drug development.
Role of PK sample analysis in drug development
CRO labs offer bioanalysis services at all stages of drug development, including discovery studies, preclinical and clinical assessment, and other supplementary laboratory services. Besides, sponsors can hire more than one CRO lab for the same project. This selection depends on the services, specialization, and geographical area. Some CRO labs specialize in a specific therapeutic area, while others may offer a broad range of analytical services.
Today, there is an increasing trend with sponsors heavily reliant on CROs to help them throughout drug development. CROs are vital in preclinical and clinical studies. CRO labs can provide in vitro and in vivo assessments of a drug product and help sponsors file IND and ANDA applications. Post approval from the regulatory bodies, CRO labs help sponsors transition the therapeutic candidate through different phases of clinical trials. Clinical trials can take anywhere between 3 to 7 years. Many sponsors recruit CRO labs to conduct all the studies from phase I to phase III clinical trials. Besides, many CROs also specialize in post-marketing assessments and help sponsors evaluate the safety and efficacy of a drug product in the real world.
All clinical studies rely on enrolling study participants. Before beginning PK analysis in clinical trials, a CRO lab recruits study participants for different phases of the human trials. These studies help sponsors understand the effect of drug treatment on human subjects. Besides, once a drug is tested in a clinical trial, the CRO will help organize the entire data for regulatory submission.
Benefits of using a CRO lab
As bioanalytical CROs take care of all bioanalytical studies from drug discovery to drug development, pharmaceutical and drug development companies can focus on more complex matters.
Most CROs are exposed to a broad range of drug development projects. Hence, they have an established system to monitor and streamline project management, patient care, and data collection.
CRO can help sponsors save time and money. A reliable analytical CRO will lower the overall costs of developing a drug product.
Bioanalytical CROs are ever-ready. They begin their work as soon as a contract is initiated.
CRO labs have expertise in handling projects according to international research markets with different regulations.
Pharmacokinetic CROs have an open and strategic alliance around clinical trial priorities and completion. This system allows pharmaceutical companies and drug developers to resolve issues around operational systems and business culture and focus on specific studies such as PK ADA assessments.
Besides, CROs have contacts with clinical trial sites in specific locations to ensure higher study subject enrollments.