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AML Adds Clinical Quality and Compliance Services
Linden, Belgium: – Benelux clinical research service provider AML Clinical Services has added an independent Clinical Quality & Compliance (CQC) Department to its service offering. The new service became operational in mid-January under the leadership of Head of the Department Manon Gadellaa.
Ms. Gadellaa has 20 years experience in Clinical Research with over 10 years’ experience in Quality Assurance and Management, including senior compliance and assurance roles at Synthon, Novartis, Quintiles and MSD (Organon).
Her CQC department will not only provide a comprehensive internal clinical quality and compliance program within AML but will also provide services to external clients. The department will advise companies on ensuring adherence to protocols and international regulatory guidelines, verification of integrity of trial data and protecting research subjects’ rights and welfare.
The AML GCP audit and consulting service includes:
• Clinical quality assurance audits
• Clinical investigator site audits (routine, for cause, and pre-inspection audits)
• Clinical database audits and study report reviews
• Clinical study document reviews
• System audits, to assess standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed
• Vendor audits, to evaluate vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations
• Support in set up and maintenance of quality systems and quality documents
• Change control and change management
• Inspection support, including mock visits
• Risk assessment and trend analysis
• Training of quality assurance and clinical research personnel
AML Clinical Services is a unique Contract Research Organization (CRO) that provides focused clinical research services to pharmaceutical, medical device and biotechnology companies, contract research organisations, research sites as well as universities operating in the Benelux countries.
Based at Linden, near Brussels, AML fields a dedicated team of highly skilled clinical research associates, project managers and quality assurance assistants with broad therapeutic expertise and experience.
AML’s services include feasibility studies, regulatory submission and approval of clinical trials, investigator site support and trial monitoring and quality assurance services. The company operates exclusively within Belgium, Netherland ad Luxembourg to maximize specialist knowledge of local conditions and regulations. Similarly, AML retains a small-scaled organizational model to guarantee close oversight, commitment, loyalty and low turnover, with all services retained in-house.
AML Clinical Services bvba
Anne-Mie Lenaers, Managing Director
Tel: +32 (0)16 78 21 70
For more information about AML’s clinical quality and compliance services, please contact AML Clinical Services directly.