In Clinical Research, Medical Writing starts at a very early stage of planning and will continue to remain as a top priority throughout regulatory approval, execution, management, trial close out, submission of Clinical Trial Reports, and also in Post Marketing Surveillance.
Since we have necessary regulatory, technical, and operational experience, we efficiently cater to the complex medical writing requirements of our clients. With the advent of online communication and video-based training, the clarity and transparency that our experts provide would complement and save the costs, time, and energy of all the stakeholders in the project.
Our Medical Writing services in Clinical Research include (but not limited to):
Preparation of Protocol Synopsis and Protocol
Compiling Regulatory Dossiers
Preparation of Informed Consent Documents & Carrying out Translations
Designing Case Report Forms (CRFs)
Preparation of Investigators’ Brochure and Project Training materials
Preparation and Archival of Trial Master File (TMF) and Site Master File (SMF)
Conceptualising Patient Diaries
Composing Clinical Study Reports
Other Reports as per Sponsor/ Regulatory Requirements