Clinical Trials Project Management

At ARIRDMSCRO, our Clinical Project Manager’s are professional’s, who applies the definition of project management to the field of clinical research to ensure that all stages of a clinical trial are properly managed, the objectives of the trial are achieved on time, budget, quality, regulatory compliance of compitant authority of geographical region and in adherence to Indian GCP, ICMR guidelines and ICH-GCP. The safety of the participating clinical trials volunteer population is always paramount above all study efficacy assessment parameter’s, as defined in study protocol.

A well-structured protocol for a clinical trial may be able to answer almost all clinical questions, but it cannot be deemed enough to ensure success, in the face of incompetent management of time, human and economic resources. To address this problem, a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects.

At ARIRDMSCRO our project management methodologies always strive to benefit both the managerial and scientific aspects of drug or medical devices clinical trials projects and reduce budget redundancies.

A clinical trial has many characteristics in common with other types of business projects as is defined in the project management book of knowledge. These characteristics include but not limited to the following:

There are pre-defined objectives to be achieved.
Identified resources are necessary to achieve these objectives.
Activities should be planned to achieve the objectives.
The work should be monitored constantly.
The criteria for evaluating the results should be defined.
The results should be evaluated.

The project is closed when the objectives have been achieved or when it is terminated, as its set objectives shall not or cannot be met, or when the need for the project no longer exists.

Clinical trial management is most simply defined as the process that an organization follows to ensure that quality (defined as minimized risks with clean data) is delivered efficiently and punctually. It refers to a standards-driven process that a project manager initiates and follows in order to successfully manage clinical trial sites, clinical research associates, and workflow by using clinical trial management tools or software. Prolonged timelines and heavy costs related to large trials have prompted a new focus on more efficient clinical trial management. All current pharmaceuticals and biotech clients are currently looking for CRO’s which can help optimize their either existing clinical trials portfolio or drug/device clinical trials discovery development process. We at ARIRDMSCRO, constantly are working round the clock to try and maximise the possibility to dramatically reduce the total cost of a clinical trial by 20% – 40% without compromising the scientific validity of the results. Given the modest effect of the most beneficial treatments and the dangers inherent in failing to identify risks before the marketing of any drug/device e.g.: cardiovascular drugs, in particular, the importance of clinical trial expenses is increasing in cardiovascular medicine, where the emphasis is on large trials with adequate sample sizes in order to detect the clinically relevant differences. Though the reduction in the sample size would decrease expenses, but it is not likely to provide adequate power to determine the risks and benefits of a new drug/device or existing treatment options (For Generics).