Clinical Research Operational Services

AML Clinical Services provides focused clinical research operational services to pharmaceutical, medical device and biotechnology companies, contract research organisations (CROs) and research sites. A dedicated team of Clinical Trial Managers and experienced Clinical Research Associates (CRAs) is available to assist in any stage of the conduct of clinical studies, in any therapeutic area. We have experience in pre-marketing as well as late phase and post-marketing studies.

AML’s clinical research services are available within Belgium, The Netherlands and Luxembourg. We deliberately limit our services to the Benelux region to ensure full knowledge of local regulations, culture, healthcare structures and for most responsive coverage. Our employees are fluent in Dutch, French and English and have a basic knowledge of German.

Similarly, AML retains a small-scaled organizational model to guarantee close oversight, commitment, loyalty and low turnover. We do not work with contractors; all staff are AML-employees. Our employees are valued for their high experience and dedication to their responsibilities.

Our clinical research operational services include:

Clinical trial Monitoring
• Research Site selection and pre-study assessments
• Site selection and initiation
• Regular monitoring (both remote monitoring and on-site visits)
• Close-out visits
• Secondary monitoring
Clinical trial Management
• Review and assistance in writing of protocol and monitoring plan.
• Project tracking /status reporting
• Organisation of investigator’s meetings
• Research site contract and budget negotiation
• Document development (Patient information & Consent Form, Diary cards, Subject Cards, etc.)
• Enhancement of Subject recruitment
Feasibility
• Compatibility checks on protocol/clinical study plan and set-up with local healthcare services (personnel, equipment, …)
• Availability of patient population and patient willingness for participation
• Assessing participation interest at research site level
• Checks for impact of any ongoing competitive trials
• Regulatory requirements and approval timelines
Regulatory
• Request Trial Authorization to Competent Authorities and Ethics Committees
• Consultancy in regulatory requirements (e.g. labelling of IP)
Training
• Clinical training for research site personnel and CRAs
• ICH-GCP training
• Training in international guidelines and local regulations

For more information about clinical research services, please contact AML Clinical Services directly.