Clinical study services We offer comprehensive services for phase I–IV drug studies (human and animals), medical device investigations, and food and nutrition studies. We are keen to provide you flexible solutions for a complete package extending from study planning to final reporting, including protocol preparation, project management, monitoring, data management, and statistical evaluation. Our services include also formulation development, manufacturing of investigational medicinal products (IMPs), QP certification, development and validation of analytical methods and stability studies for IMPs. We also provide outsourcing services and flexible solutions for investigator-initiated studies. Medfiles has a complete range of SOPs (standard operation procedures) for both clinical studies and medical device investigations. In addition, regulatory requirements for clinical studies and later submissions both for pharma and food area are taken into account in our clinical services. We can also help you with register studies, health economics in clinical trials, consultation and training. Clinical study Study planning • Study feasibility • Schedule planning • Consultation • Clinical research plans Protocol writing • Clinical studies with medicinal products (GCP) • Clinical studies with food and food ingredients (applicable GCP and EFSA requirements • Medical device investigations (EN ISO 14155) • Performance evaluation of IVDs (EN13612) • Protocol review from regulatory perspective Medical writing • IB/IMPD Site evaluation • Site feasibility questionnaires • Principal investigator (PI) identification Clinical study applications • Ethics committee submissions • Regulatory submissions / CTA • Translations Project coordination • Project management • Status reporting • Site staff training • Clinical monitoring • TMF maintenance • Meeting arrangements Pharmacovigilance › Pharmacovigilance Data management • Data handling (paper/electronic CRFs) • Medical coding (MedDRA) Statistics • Sample size calculation • Tables and data listings Report writing • Clinical studies (GCP) • Medical device investigations (EN ISO 14155) • Performance evaluation (EN 13612) • Publications Investigational medicinal product (IMP) • Formulation development • Production (non-sterile products) • QP certification • Analytical method development and validation • Stability studies Bioavailability and Bioequivalence studies • Selection of an appropriate study design • Writing of study protocols and informed consent forms • Independent ethics committee and CA approvals • Data management and statistics • Pharmacokinetic and statistical data evaluation • Reporting of study results • Archiving of all study-related data • Quality assurance These services are offered in collaboration with our Finnish and Estonian partners: • Phase I units • Bioanalytical service providers Food and nutrition studies › Food and Nutrition services We offer studies for substantiation of health claims on foods, safety of novel foods, and efficacy of foods for special groups: • Selection of an appropriate study design / outcome markers • Writing of study protocols • Informed consent forms, diaries and records (incl. diet monitoring) and CRFs • Site selection and agreements • Independent ethics committee and CA approvals • Data management and statistics • Reporting of study results • Archiving of all study-related data Experience Phases Therapeutic areas For more information please contact Key account manager Kirsi Pärri-Hedman Services Analytical services Microbiology Product development and production of IMPs Pharmaceutical documentation Medical and regulatory writing Clinical study services Regulatory affairs human and veterinary Pharmacovigilance Health economics and market access services Cosmetics Medical devices Food and nutrition services QP, quality and distribution practices Translation services © Copyright Oy Medfiles Ltd. All rights reserved. Extranet Volttikatu 5, FI-70700 Kuopio, FINLAND | Tel. + 358 20 7446 800 Design: Aihe