Clinical research determines the safety, efficacy and effectiveness of medicines, diagnostic products, cosmetics and foods intended to be used for healthy human living. Clinical trials are done prior to the release of a product into the market by comparing it against a standard or placebo (inactive substance) treatment. These trials are designed and conducted systematically in four phases (Phase I, II, III, IV) which are monitored by the expert professionals. An extensive clinical data related to investigational product is generated as a result of clinical trials. Expert clinical data management (CDM) vitally affects the success of an investigational product under clinical trial.
CDM professionals collect clinical data with case report form (eCRF), a tool which may be either electronic or paper based. Paper based CRF data has to be entered and stored into the electronic systems by the data entry personnel. At the end of each trial CDM ensure that the data is collected, accounted, managed, verified, validated and locked in the databases. Data thus managed is analysed using sophisticated analytical software to determine the trial results.
In addition to the assessment of therapeutic profile of an investigational product, prevention of potential risks of investigation drug to humans is vital. This is ensured through a regulated system referred to as "pharmacovigilance". It includes reporting and optimization of hostile effects of treatment throughout its lifetime expectancy right from clinical trials to the postmarketing uses. Thus, pharmacovigilance is considered as a critical component for determining the benefit to risk ratio of treatment.  During or post clinical trial, toxic effects may be reports as adverse events (AEs), serious adverse events (SAEs) or as clinically relevant adverse events (CRAEs). SAEs, once noted, may actually lead to very specific identified warnings on the product labels or even withdrawal of the drug. Various adverse drug reaction monitoring centres are being employed for reporting and entering safety data in the databases like Oracle Argus or internationally to UPSALA monitoring using Vigiflow software.
Sponsor, the company which pays for a clinical trial has the onus for trial management, CDM and pharmacovigilance in accordance with regulatory guidelines. However, with rising market pressure sponsor transfers such responsibilities to specialized organization called referred to as CRO (Clinical/Contract Research Organization). A CRO assists the sponsors in cutting down the drug development lifecycle thus accelerating the drug development process, reduction in the overall costs and approval of a novel drug or medical device from a regulatory body. An experienced CRO is capable of simplifying the problem of inadequate resources by making use of its assets and providing its services in an adequate manner.
Clinical research organization provides Clinical Trial Services (CTS) that includes project management and monitoring of trials from study initiation up to the final reporting. These research organizations offer in-depth knowledge of clinical development including: feasibility, site selection, monitoring, project management, protocol preparation, application to authorities and ethics committees, primary contact for the client to ensure optimal project flow, and flexible project work in accordance with the client requirements. Other services include pharmacovigilance and medical writing which are crucial for corporate success.  CTS team consists of large number of professionals for managing the clinical trials such as project managers, clinical research associates, clinical research coordinators, clinical trial assistants, clinical data managers, statistical analysts, medical writers, drug safety professionals and information technology experts.
Clinical research is the mainstay of drug development process forming basis of sponsor's commercial fate. However, complexity of trials and mounting market pressure had resulted in vital role of CROs alongside sponsors. Specialized services including trial management, CDM, pharmacovigilance and medical writing provided by CROs have ensure accelerated drug development, commercial success to sponsor and safety to the patients.