Significance of Regulatory Services in Clinical Trials by LotusLabs


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									                      Significance of Regulatory Services in Clinical Trials

According to GCP (Good Clinical Practice) research guidelines there is a certain standard for the conduct,
design, monitoring, performance, recording, auditing, reporting and analyzing of clinical trials. This helps
to offer assurance that the data and reported outcomes are accurate and reliable. It also ensures that
the integrity, rights and the privacy of clinical trial subjects are secured.

Regulatory services, standards and quality assurance in clinical trials are essential, as it results in the
following benefits:

    ●   Reduces the risk
    ●   Secures and protects research subjects
    ●   Offers quality information and outcomes
    ●   Results in high-quality research and good science

Regulatory services and quality assurance form an essential aspect of many CRO’s (Clinical Research
Organization) in India today. The CRO’s have their specialized team for audit compliance and regulatory
services that are in turn supported by an in-depth know-how of the local regulatory processes and
efficient liaison with multiple regulatory agencies that ensures the efficiency in clinical trial approval

It has been observed that the Indian CRO’s have experience in conducting numerous audits with Indian
as well as global regulatory agencies. In addition to that, they also have made study submission to
various countries and include places such as MOH Israel, NPCB Malaysia and National Medicines &
Poisons Board, Republic of Sudan. Some of the services comprise the following:

    ●   Formulation of regulatory strategies
    ●   Compilation of the clinical trial application
    ●   Submission and follow-up of the application
    ●   Responding to regulatory agency queries
    ●   Procurement of drug import licenses
    ●   Procurement of NOC for export of biological samples
    ●   Tracking of applications and approvals
    ●   Safety Reporting
    ●   Submission of Clinical Safety Report (CSR)
    ●   Renewal of Import License

The modern day biomedical technologies are superior as compared to the ones that were available
earlier. As a result of which today's regulatory standards are followed diligently in various medical
researchers in subjects such as medical writing, biometrics, bioavailability, bioequivalence, and other
Bioanalytical studies. These apart, fully controlled clinical trials under the guidance of ethics committees
and comply with the best regulatory standards are required to be conducted to set up reliable and
accurate data. This data is further used to answer major clinical queries and set up the efficacy and
safety profile of clinical therapy. The standard will be randomized control trials (RCT’s) in order to
avert any bias and expansion to global multi-center studies will also be essential. Furthermore, this
will also offer the required scientific evidence for effective and safe clinical trials. Simultaneously, the
comparative medical studies that involve direct comparison with present therapies will also be required
to answer some of the modern day medical concerns.

Read More About: Clinical Pharmacokinetic

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