Investigator Initiated Studies
Participating in clinical trials can be a very positive and productive experience for investigators and study coördinators. The set up, the daily administration and the collection of all data can also be a challenge for all people involved. Clinitude will assist investigators with the preparation, documentation and monitoring/collection of data. Clinitude will help you to comply with institutional and governmental policies and regulations in managing your clinical trial.
National laws govern the proper conduct of clinical trials and the protection of participants. In addition, various strict ethical and technical guidelines have been adopted at European and international levels.
Clinitude can help you with:
– preparation and submission of regulatory dossiers
– Clinical Trial applications and notifications
– Submissions to Competant Authorities and Ethics Committees
– Review of translated clinical study material.
– Overall regulatory support throughout the study
– Quality control of documents
Feasibility and Site Selection
A feasibility study is one of the key success factor of any study. Our database as well as our relationship with local authorities and physicians allow Clinitude to provide feasibility studies in the shortest possible timeframes. Sites who have been identified during the feasibility assessment will be selected during the selection process agreed between study sponsor and Clinitude.
Clinitude Clinical Research Associates (CRAs) play a major role in the successful conduct of a study. An open and effective communication allows CRAs to provide support and training to the site staff securing patient safety, data quality and maximizing patient enrolment.
Clinitude operates in full compliance with international and local regulations as well as with ethical and scientific standards.
Our CRAs have a university degree and are trilingual (Flemish, French and English). CRAs work closely with the sites to ensure compliance with study protocols, industry standards, data collection and regulatory requirements.
Clinitude CRAs monitor phase I – Phase IV clinical trial: from prestudy until close out.
Our auditing goal is to protect human participants while achieving clinical trial product safety and efficacy objectives.
Clinitude provides following auditing services:
– Investigative Site Audits
– Study Documentation Audits
Late Phase Studies: Observational Studies and Registry Studies
Late-phase clinical trials are designed to determine effectiveness and further study the safety of an investigational drug in human patients. Our experience of support services provides complementary resources and expertise to enhance your studies.