Types of Document
Clinical trials dossiers and component documents such as study summary tables.
Integrated Clinical Study Reports (Phase 1, 2, 3 and 4) suitable for MAA and NDA submissions, including tabulations, patient safety narratives, prepared according to customer specifications and current guidelines.
Clinical Study Protocols and Investigator Brochures prepared according to customer specifications and the ICH Harmonised Guideline for Good Clinical Practice (GCP).
Preparation of review articles, manuscripts, abstracts and monographs for publication, and editing of these types of document.
Periodic safety update reports.
Training materials.
Additionally, independent Review, quality control and audit of clinical documents, for example clinical study reports.
Independent quality control of documents produced can be arranged.
Therapeutic Areas
A wide range of therapeutic areas covered, including infectious diseases and vaccines, cardiovascular and peripheral vascular disease, ophthalmology, musculoskeletal disease, hepatic disease, CNS disorders, respiratory disease, oncology, endocrinology and urogenital disease. Phase 1 topics covered include: sensitisation and irritation of topical products; bioequivalence; pharmacokinetics; interactions; and pharmacodynamics.
Facilities
Short or long term projects can be undertaken, in the UK and internationally, from
a fully-
Margaret has friendly and good communication skills and interactions within the customer's project team. Agreed timelines are adhered to.
Customer focused high quality documents, delivered on time and to budget, of the following type:
“ The Report looks excellent to me..”
