Archer Research Information

Archer Research is a full-service Contract Research Organization (CRO) specialized in clinical research with Medical Devices, covering studies all over Europe and The UK. For our clients, we are a partner from the very beginning along the full lifecycle of their clinical development. Whether you are an early-stage start-up or a large organization or an investigator, we can help you achieve your strategic goals through sound clinical and regulatory planning and execution. We are experts in setting up and managing pre-CE as well as post-market clinical follow-up studies from A to Z. - Regulatory and clinical strategy, clinical development planning - Clinical evidence, literature review, gap assessment of available data - Medical writing from clinical evaluation (CEP/CER) to clinical study protocol/CIP, ICF to Clinical Study Report and manuscript. - Investigational site selection, Ethics & Regulatory submissions, contract set-up, payment management, study set-up & planning. - Case report form (CRF) design, electronic data capture (EDC) programming, biostatistical analysis and sample size calculation, as well as Data Management. - Project Management and Study monitoring activities (risk-based, remote and/or on-site). - Expert in the Medical Device Regulation (EU MDR) and the requirements for medical device companies in obtaining valuable clinical data compliant with ISO14155 and GDPR. Why do we stand out? - Full-service CRO - Specialized in Medical Devices - Personal approach - Covering Europe & The UK Welcome to come in for a coffee in our offices in Diepenbeek, Belgium, or to meet virtually if you are interested to know more about Archer! Only an email away via info@archerresearch.eu. Feel free to follow our LinkedIn page and visit our website to stay up to date about our services, our achievements and the amazing people behind Archer. http://archerresearch.eu