Clinical Trial Operations in General

The team of clinical operations conducts Phase I-IV clinical trials of new drugs and development, maintaining high ethical standards, quality and confidentiality. A team of highly trained professionals with good amount of knowledge and experience in different therapeutic areas manage the studies of national and international clients.

 

Here is a brief overview of the various functions involved in the clinical trial operations:

 

Management Study:

All projects require the execution of well-organized project managers trained in ICH GCP rating agencies and national and international regulations to monitor the activities of the study sites. This pooling with a proper plan offers a reactive approach to successful study time. Issues related to the Protocol and other studies related to AE / SAE was reported the project manager and medical monitoring, ensuring reliability of data from clinical trials.

 

Site Management:

Clinical trial operations team is dedicated to the rapid activation of the site for clinical trials. They select sites based on the material during the feasibility of a good patient flow, and other protocols. Team prepares to plan recruitment and unique to each site, with particular attention to the strengths and experience of the site. They must have an established relationship with the research sites to work closely with each site to develop a successful recruitment and strategies. In addition, the team needed to identify new sites and investigators, and updates the database, to provide adequate training for them. All clinical studies of large and complex can be effectively carried out by qualified clinical project managers and highly qualified CRA with the proper planning and implementation.

 

Clinical follow-up:

Rating agencies with the life sciences and medical history and strong organizational skills are like the pillars of clinical operations department. In addition they must have, good communication skills oral and written. The rating agencies add value to execute and perform well in clinical projects. They travel to research sites per protocol or sponsor needs by ensuring the integrity, data quality, compliance with the protocol, SOPs, the requirements of rules.

 

Clinical Trial Supply Management:

Another major activity of the management is clinical operations of clinical supplies. They build logistic models according to SOP (CRO / sponsor) and rules to meet the specific needs of the developer. Based on the requirements sponsor department is handles the task of destroying the tissue. The team also provides assistance to other activities as obtaining import licenses and customs clearance.

 

Supplier Management:

This section has hands on experience with vendor management with a single point of promising a permanent communication and co - ordination with suppliers.

 

Indian clinical research:

Although all staff is required to perform a clinical trial are common in India today, but there is still a need to change the course of construction. The DCGI is responsible for approving Clinical trial regulations in India. The FDA gives its approval to an average of 30 days, but most trials in the United States are delayed by the time it takes to save the patients. The potential for rapid patient recruitment in India to some extent compensate for the delay in approvals by regulators.