The quality and safety of our clinical trials
CAP RESEARCH conducts each of the clinical trial in accordance to the legal provisions of Mauritius (the Clinical Trial Act) as well as international legal provisions on therapeutic trials. Each study or project is subject to the approval of the Clinical Research Regulatory Council and that of the Ethics Committee. All studies are conducted within strict Good Clinical Practice (GCP), with procedures that ensures the safety of volunteers/patients whilst maintaining the authenticity and quality of scientific data.
CAP RESEARCH offers customised services so as to cater for the demands of the most demanding of its partners:
Our teams can design tailor made clinical studies whilst writing your protocols, synopsis, and informed consent forms. We are autonomous and prepare folders and documents pertaining to clinical studies (investigator, laboratory and pharmacy files) and also the subject’s source documents which ensure that protocols are correctly followed.
Our teams are fully aware of the local and international regulations when submitting and following up your applications for authorisation / opinion from the Clinical Research and Regulatory Council of Mauritius Ethics Committee.
Performed according to the Good Clinical Practices, we recruit healthy volunteers or patients according to the wanted criteria of the study. We always attain our set objectives.
We have in our centre a medical team consisting of doctors, nurses, etc.; and an administrative team (CRA investigators) totally dedicated to CAP RESEARCH who design the protocols of each study according to international standards in terms of clinical trial (EMA , FDA) whilst applying rigorous internal procedures so as to provide a high standard of work and reliable data.
We collect information from the participants of clinical studies with the purpose of disbursing their allowance.
With our extensive experience in clinical trials (over 30 years), we are here to guide you in the best possible way to build up your project.
Our teams can manage part or all of your projects so that you achieve the clinical testing side of your research with uttermost confidence:
- Competent : Our teams are qualified and have extensive experience in terms of project management
- Conscientious : we work with independent partners who have a high level of quality equivalent to that of CAP RESEARCH
- Flexible : we adapt ourselves to your needs, budget and deadlines.
- Unique : you correspond with a single intermediary
Activities performed by our various partners
- Preparation / packaging of pharmaceutical units
- Certified Medical translation (certificate of translation possible)
- Statistics (safety and pK)
- External laboratory analysis (e.g., viral loads)
- Local laboratory services (e.g. standard laboratory tests)
- Laboratory for analysing pK
- Data management