The new drug development program passes through various stages. It needs expertise, sophisticated instruments, validated bioanalytical methods, lots of money, time, patience, and approval from authorities like the FDA.
How FDA approves drug?
Centre for Drug Evaluation and Research (CDER) is a unit of the Food and Drug Administration (FDA) that keeps a watch for the potential drugs that seek commercialization approval. The biotech and pharmaceutical companies have to carry out extensive research and testing and furnish documents of results to CDER. A team of chemists, doctors, pharmacokinetic, and scientists review the results. Their reviews form the basis for approval or disapproval of the drug by the FDA.
Phases of Drug development
The new drug development program has five stages:
- Phase- I – Discovery and Development
- Phase – II – Pre-Clinical research
- Phase – III – Clinical Research
- Step – IV – FDA review
- Phase – V – Post-market monitoring by FDA
CRO in Clinical Research
The third phase – Clinical research, is the phase of animal and human trials of the drug. It needs a top level of expertise, sophisticated instruments, and highly trained technicians. Most pharma and biotech outsource these trials to some professional contract-based research organizations called Contract Research Organizations or CRO.
Role of CRO in Clinical Research for FDA drug approval
A Pharma CRO or Biotech CRO is a group of thoroughly skilled experts for handling complex drug development programs that demand the knowledge of new regulatory and clinical approaches and the know-how of implementing and completing new drug development programs. CRO services biotech firms, government organizations, pharmaceutical units, medical device units, Universities, and other research organizations. Here are the roles that the CRO play in the development and FDA approval of the new drug:
- Biopharmaceutical development
Bioanalysis CRO helps in proper development and characterization of the new drug, and therefore, specifying its significant properties.
- Development of a bioanalytical method and its validation
CRO can help Biopharma companies in the development and validation of these methods. New drug approval is not possible without the use of a validated analytical method.
- Carrying out clinical research and trials
Clinical trials have four sub-phases. It concerns the examination of the new drug on human volunteers. CRO’s responsibility is to arrange for the proper and useful conduction of these trials and document the results. FDA does not approve any new drug without these documents.
- Commercialization of the new drug
CRO indicates the attributes, counter-indications, side effects, dose-response, and so on of a drug that can help the pharma company plan its commercialization strategy.
CRO also helps assess, detect, and prevent and understand the adverse effects or any other problem related to the drug under investigation for patient’s safety.
Contract Research Organizations are the backbone of any new drug development endeavor. The biotech or pharma company neither have the expertise nor the sophisticated instruments to carry out clinical trials.
CRO helps in not only proper conduction of bioequivalence clinical trials but also the rapid approval from the FDA.