A REVIEW ON CLINICAL DRUG DVELOPMENT PATHWAYS

Ishita, Asha Devi*, Muskan Sharma, Priyanka Kaundal

ABSTRACT

Effective trial management is necessary to oversee clinical trials of any size and complexity, and during the past three decades, trialists have created and improved the trial management wheel. We propose that it is time to create standard trial management principles and build strong protocols to enhance the timely and successful implementation of significant clinical studies for patient benefit techniques for assessment. This outlines the steps and processes required in organizing, carrying out, and disclosing monitoring activities for extensive clinical trials of pharmaceutical and experimental items, with an emphasis on those carried out in environments with limited resources. Any clinical study must include clinical trial monitoring to guarantee protocol compliance, data quality, and subject safety. In recent years, regulatory bodies and industry professionals such as a risk-based strategy to clinical trials has been promoted by the USFDA and ICH. Clinical trial monitoring and auditing is a complicated procedure, and using traditional auditing techniques raises the cost of clinical studies. This procedure outlines methods for clinical trial cost-effective monitoring. By examining all issues and expenses, sampling techniques for source documentation can be utilized to reduce costs without compromising quality. Clinical research activities and documentation are subjected to an independent, methodical assessment to ascertain whether the procedures involved in starting and overseeing this clinical research were carried out and whether the data was gathered, examined, and reported in accordance with standard operating procedures with the protocol. System audits ought to be controllable and reasonably sized given the available resources (may be handled). Audits must be planned and carried out to produce outcomes that are acceptable. Above all, avoid downgrading your audit program and leave time for audits that aren't scheduled.

Keywords: Manage, Monitor, Audit, Clinical Trial, Quality Evaluate.