MAIA Consulting Sarl Information

Founded as a spin-off following the closure of the Merck Serono Geneva headquarters, we are based in Geneva, Switzerland and we serve clients worldwide. Read our full brochure here: http://maiaconsulting.eu/documents/Brochure2019MAIA.pdf 1. Medical Writing: Our Medical Writers (internal or partners) have a wide breadth of knowledge and experience. Regulatory and Clinical Documents • ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV • Study Protocols • Clinical and non-clinical sections of the Common Technical Document (CTD) • Investigator Brochures • Patient safety narratives • Patient information including Informed Consent and Patient Brochures • Pharmacovigilance documents such as Periodic Safety Update Reports Quality Documents • Standard Operating Procedures (SOPs) • Work Instructions Scientific and Medical Communications: MAIA is a member of the Drug Information Association (DIA) and the European Medical Writers Association (EMWA) • Conference materials (abstracts, poster presentations and slide sets) • Manuscripts • Educational material for patients, healthcare professionals and pharmaceutical industry personnel • Medical marketing reviews and reports • Literature reviews 2. Clinical Operations: We have a long experience of clinical trials and are able to assist with the following: • Concept sheet development, • Protocol authoring, • IND/CTA preparation, • Informed patient consent development, • Protocol amendments management, • Trial team training, • Adjudication (including e-Adjudication) • Central monitoring (including RBM) 3. Supportive Technologies: We are recognized experts in a number of R&D supportive technologies: • EDC (electronic data capture) • ePRO (electronic patient-reported outcomes) • RBM (risk-based monitoring) • e-Adjudication • EDM (electronic document management) • e-submissions • RIM (regulatory information management) • SCM (structured content management)