None of the clinical trials can be completed without a project management team. For a successful completion of every clinical trial a project manager is its backbone. Team can be built only by the company which has long experience in the field. The companies are undertaking multiple projects at different times so they are enrolling fresh staff at the beginning level which starts with the interns, and these grow in the field and get promoted with successful undertaking of projects. Therefore they have meritorious team that manages the specific clinical trial. The team which is led by a Project Manager comprises of experienced:

  • Clinical Research Associates -CRA’s
  • Clinical Research Coordinators -CRC’s
  • Clinical Trial Assistants -CTA’s
  • The team as a whole is committed to provide timely execution of good quality and economical management of the clinical operations.

project-management-of-Clinical-trials-in-India

What is in offering for client through the project management?

  • Studying the start-up
  • Planning regarding project milestone, its feasibility assessment, Investigator site selection
  • Conducting & organizing Investigator meetings
  • Investigation and Site personnel training
  • Providing input in the development of essential trial documents like – Protocol, ICF & CRF
  • Facilitating study activities and provision of key deliverables
  • Providing the team and its partners with ongoing communication for the progress of study, procedures and the policies
  • Monitoring the study budgets and related financial procedures and management of variances
  • Management of the supplies of clinical trial & investigational product
  • Monitoring of the study throughout the process
  • Training/ Education

The whole process of project management is run under the guidelines of FDA. It is a scientific approach so has no room for error. The vitality of the clinical research is maintained by providing training to all the professionals related to clinical research which includes

  • Physicians
  • Dentists
  • Nurses
  • Dieticians
  • Epidemiologists
  • Biostatisticians
  • Informatics specialists

Project Management of Clinical Trials in India work in the interdisciplinary and team-oriented environments that is characterized in emerging research efforts.

Tailor-made solutions are delivered for the clients in early and late phase of clinical trials. Equipped with a team of highly experienced project managers and CRAs, one can rely on the team maintaining international quality standards in completing the project in time. To reach to the post of project manager one has to undergo all the steps and be part of different stages. A well- educated and qualified person only can reach the stage of Project Manager. He also has to be aware about certain norms like:

  • A country’s study plan has to be followed diligently, while maintaining its
  • Regulatory environment
  • Disease prevalence
  • Patient access
  • Therapeutic specialists
  • Advantages of quality efficiency with Cross-functional teams
  • network of offices following same working and procedures
  • Worldwide use of solitary Trial Management System
  • Seamless collaboration amongst trial management office
  • International and local trial management
  • Clinical development program consultation
  • Study design and writing protocol