Clinical project management

Planning and carrying out a clinical trial while fulfilling all legal and regulatory requirements is a complex and time consuming task. At the TCC, we provide full-service clinical project management. This enables you to concentrate on your core tasks, while still being actively involved in clinical research.

Our clinical project management services cover the planning, coordination and implementation of all types of clinical studies. Our clinical project managers support and carry out a range of activities essential to the smooth and correct running of a study. These include:

  • the coordination of all aspects of the communication between you, your staff, study sponsors and the TCC, icluding the organizations of meetings and teleconferences.

  • project planning.

  • budget management.

  • quality management.

  • cordination of submissions to ethics committees and regulatory authorities.

  • budget management.

  • preparation and distribution of paper case report forms, patient information letters, informed consent forms, study newsletters and other documentation.

  • organisation of teleconferences and investigator meetings.

  • and writing study progress reports.

At the TCC, we have extensive experience in coordinating trials and other clinical studies based at single and multiple centres in different countries and languages. We can:

  • work within international legislative guidelines.

  • select study sites and organise patient selection.

  • standardise logistic aspects across sites.

  • inform individual investigators or sites about irregularities in their data.

  • monitor compliance with the study protocol at all sites.

  • monitor the overall and local progression of the study.

  • and coordinate clinical reporting to all sites and ethics committees.

In addition, we develop protocols and other relevant documents for each study centre and can arrange for them to be translated. Hence, we can provide clinical project management services for all types of clinical study, even if the study sites are spread across a large geographical area.