Mapi provides Medical Writing services supporting the collection, organization, writing, editing, and production across the entire range of medical and scientific documentation to support your product lifecycle managment. We offer an adaptable and efficient process for any project, including:
- Scientific communication (abstracts, manuscripts, posters, and journal articles)
- Medical and scientific literature reviews
- Clinical development plans
- Protocol development in all therapeutic areas, multiple study designs, across the entire spectrum of endpoints including regulatory mandated studies
- Clinical study reports
- Clinical sections of common technical documents (CTDs)
- Patient and Physician facing materials including patient information sheet, informed consent, and case report forms
- SOP development
- Informed Consent Forms
- Preclinical study reports, expert reports, and summaries
- Pre-FDA meeting briefing documents
- Preparation of EU Regulatory Agency pre-meeting package
- Orphan medicinal product submissions (designations & renewals)
- Investigator brochures and annual updates
- Pharmacovigilance documents, including Periodic safety update reports (PSURs)
- Benefit/risk assessment reports
- Clinical Outcomes Assessments
- Stakeholder training and educational tools
- RMP/REMS document such as RMP/REMS content, REMS authoring, literature review part, educational material, RMP summary
Combined with Mapi’s unique access to COA authors and questionnaire and scale libraries, Mapi’s in-house experienced medical writing staff produces all types of documents for clinical trials, COAs, observational studies, and HE & OR studies.
Mapi has a team of medcial writers, epidemiologists and health outcomes researchers who have extensive experience developing documents including but not limited to study protocols, value dossiers, HTA submissions, SAE narratives, clinical outcome assessments (COAs), other regulatory submission documents, study reports, manuscripts, stakeholder training and educational tools across numerous therapeutic areas. In addition to offering access to a wide range of subject matter experts Mapi also has the facility to offer in-house translation and language validation services in over 100 different languages. In addition, Mapi offers publication services related to the projects conducted by Mapi including defining publication strategy (audience, journal, messages), developing manuscripts, abstracts and posters, coordinating co-authors, submission, and answers to reviewers.
Mapi is highly experienced in the design of various study designs. Our staff is available to collaborate with you to produce a design that facilitates your goals. Mapi will advise on the study design and choice of assessment instruments which should be determined using epidemiologic principles and methodology specific to late phase studies. Mapi’s Epidemiology team is available to lead or support development of the study design and work closely with you to ensure that corporate and study objectives are met. Other members of Mapi’s study design team, including experts in medical affairs, biostatistics, regulatory affairs, project management, site management, and data management, can also provide input and review of the study design to ensure that it is feasible and consistent with regulatory guidelines.
Mapi has managed thousands of writing projects in Europe and in the Americas and is among the most recognized Health Research and Commercilization industry contributer. We rely on full-time staff of experienced medical writers, epidemiologists and health outcome researchers who have either Master or Doctorate degrees.