We provide scientific documents by a team of trained and specialized writers and experts in all major areas on request. The prepared materials are always reviewed and blessed by our in- house physicians who are therapeutically aligned for the clinical contents along the specific subject matter.
We follow the principles of:
Collectivism – common ownership of scientific discoveries
Diversity – evaluation using universal, unbiased criteria
Impartiality–abstain from conflict of interest
Controlled conviction – ideas tested and subjected to rigorous, structured scrutiny by peers
Our teams of authorities are experienced and efficient in providing the complete solution for your medical writing requirements. Our professionals achieve this in all segments of the industry including but not limited to safety, clinical development/operations, and regulatory affairs/submissions, commercial and medical affairs. Our cross functional team members would work collectively with the Project Managers, Analytical Experts, Biostatisticians and Data Managers. These unified and knowledgeable set of professionals are led by thought leaders as the subject matter experts.
Highlights –Medical Writing
Catering to more than 15 clients based in the US and among the European Union.
Completed over 2950 projects.
Reports submitted to FDA and EMA.
Dedicated experienced professional team of medical writers holding reagent scientific degrees, usually a Master’s, PhD, and/or MD. They have acquired adequate clinical trainings in the core areas of expertise. Our medical writing team works closely with leading physicians and thought leaders as needed and assigned by the clients.
Core documents included but not limited to:
Regulatory Document: New Drug Applications (NDA), Investigational New Drug Application(IND), Protocols(Preclinical as well as Clinical) including but not limited to Investigators Initiated Trials, and/or Investigators Brochure.
Safety aggregate report: PSUR, PADER, etc.
Package Insert, patients’ letter, etc.
Clinical Trial Report /Clinical Study Report–Phases I- IV.
Patient Document–Informed Consent Document including patient information sheet, patients’ pamphlets, etc.
Aggregate Reports, ad hoc reports, Dear Dr./investigator, etc. communications.
Journal articles: Original Research Material and publications, Review articles, Editorials, Case reports, Abstracts, Publication in journals, Submission to medical meetings, Posters including presentation at medical meetings, Advisory boards. Medical education materials like Monographs, Training materials, and/or prescribing information.
Commercial/ Marketing subject matters: Review Articles, Manuscripts, Case Studies, Conference Abstracts, Slide presentations, Original research, Symposia, Round tables, and marketing material not restricted to Advertisements, Public relations materials,Internet documents.
We follow the strict guidelines of:
International Committee of Medical Journal Editors uniform requirements for manuscripts submitted to biomedical journals.
Reporting guidelines for research, at the Equator Network Resource Centre
We abide by applicable regulatory guidelines (if applicable) and SOPs.
We follow strict rules of Authorship by avoiding guest- and ghost-writing.