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MAIA Consulting Sarl

MAIA Consulting Sarl


MAIA Consulting Sarl's financial review

Employees

10


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.pdf1. Medical Writing: Our Medical Writers (internal or partners) have a wide breadth of knowledge and experience. Regulatory and Clinical Documents• ICH GCP complia...
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.pdf1. 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 ReportsQuality Documents• Standard Operating Procedures (SOPs) • Work InstructionsScientific 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 reviews2. 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)

MAIA Consulting Sarl industries

Change management
Clinical project management
Clinical research
Data analytics

MAIA Consulting Sarl's financial review

Employees

10

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