For over 20+ years, DNA tech is providing high quality medical writing services for Biotech, Pharmaceutical, Consumer Health and Medical Devices companies across the Globe. Our team of well qualified and experienced Medical Writers have deep experience in writing Regulatory, Clinical, Scientific and MedCom areas. Medical writing services provide exceptional results from doctorate-trained writers.

• Clinical study reports (CSRs)

• Pharmacodynamic reports

• Pharmacokinetic reports

• Protocols

• And more

• Review of Sponsor-provided drafts of Clinical Study Protocol, other Clinical Study related documentation and creation of feedback with suggestions and recommendations which will facilitate the conduct of Clinical Study

• Review of Clinical Study related documentation and its adaptation to country and/or site-specific requirements (documentation include but is not limited to: Patient Informed Consent Form, Patient Emergency Card, Patient Questionnaires & Diaries, Investigational Medicinal Product Labels). This service can be done for initial versions provided by Sponsor as well as for revised versions following Clinical Study Protocol Amendments and changes

• Development of specific forms for use in Clinical Study (e.g., study logs, subject reimbursement forms, study newsletters, various instructions & guidelines)

• Development of Clinical Project Plans (e.g., Project Management Plan, Communication Plan, Clinical Monitoring Plan, Trial Master File Management Plan, Third Party Vendor Management Plan etc.)

• Review of Sponsor-provided drafts of Clinical Project Plans and their adaptation to country and/or site-specific requirements