Mentoring and developing junior CRAs
As mentoring is an essential leadership skill, we find it very important to help others learn, grow and become more effective in their jobs in addition to managing and motivating colleagues.
Close out visits
During the final monitoring visit, we ensure that any necessary follow-up is conducted in accordance to the applicable guidelines and SOPs.
Trial Master File maintenance
We will ensure preparation, collection and distribution of trial master file documents and maintenance of investigator site file.
Quality Assurance, Audit preparation and Follow up
Quality assurance and quality control is key to delivering the consistent quality service expected when conducting clinical trials. Throughout the conduct of a clinical trial, we take active measures toward maintaining quality. This includes direct project responsibility by Investigators, in-house training programs, and internal peer review of all technical services.
Site staff training & initiation visits
A study initiation visit's main purpose is to train the investigator and supporting study staff on the objectives of, and planned methodology for, a clinical study. We will spend a great deal of time training the site personnel and providing the opportunity for sites to raise questions.
Site evaluation & contracting
During our practice we have established excellent relationships with key investigators in every therapeutic area across Belgium and have built a comprehensive investigator database allowing us to identify and qualify the sites in shortest timelines.
Regulatory and EC submissions & amendments
We provide regulatory expertise contributing to sound decision-making and manage clinical trial applications to Competent Authorities and Ethics Committees.
Feasibility, Selection Visits and recruitment of Investigator Sites
Feasibility is key to conducting a successful clinical study. We can provide detailed feasibility information and advice according to your needs.
We have an open and friendly approach and are here to guide Investigator Sites through the recruitment process every step of the way.
Site monitoring services for Phase I-IV, medical device and late phase studies
With a strong scientific background and exhaustive experience in clinical trials methodology, we display professionalism and innovative problem solving throughout all phases of trials as well as medical device studies. We perform risk based, remote and on-site monitoring in accordance to ICH-GCP.
Who We Are
Phoenix Clinical Research is a young and dynamic company, specialized in set up and guidance of clinical trials. We provide freelance CRAs in Belgium. Phoenix Clinical Research is dedicated to conducting clinical trials that accurately measure the safety and efficacy of its candidate drugs. The company abides to set high standards in conducting its clinical research and in due course, provide patients and their physicians with the information they need to make informed treatment decisions.
The Clinical Research Associate “monitors” the research procedure and ensures that researcher’s follow the proper clinical trial protocol at all times to obtain the correct data. The CRA also controls that these processes are performed in line with regulations of the food and drug administration, FDA and Good Clinical Practice, GCP.
We can work for pharmaceuticals and biotechnology companies as well as for CROs or independent organizations.
Why Choose Us
For studies in which continuity is desired, but the budgets, resources, and workloads do not demand a full-time CRA, a freelance CRA can be the solution. Employing individuals with knowledge of local regulatory and ethics expectations can avoid delays caused by conducting a trial in diverse cultures, with differing regulatory requirements, medical practices, and languages.
We provide the most professional and dedicated freelance CRAs in Belgium you can think of. Starting from a 0,1 FTE to 1 FTE. Site vitists are possible all over Belgium so our freelance CRAs are up for any job you throw at them!