As per ICH E6(R2) 8.1, Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
Maximum care should be considered when it comes to essential documents preparation. San.K.Bio Consulting’s owner has been involved in writing and review of thousands of essential documents since the beginning of her career.
San.K.Bio Consulting can take a fresh look at your documents and bring a critical eye on:
- Protocol (and amendments)
- Informed consent forms
- Subjects’ facing documents, questionnaires
- Or any other document you might need support on
A well-written visit report is an essential part of documenting clinical trial oversight. In addition to being required by ICH guidelines, it also tells the story of the clinical trial to the regulatory authorities, demonstrating site performance and sponsor oversight during an audit or an inspection.
San.K.Bio Consulting’s owner has more than 14 years’ experience in visit reports’ review written by CRAs from worldwide. We believe reports’ review is an outstanding activity requesting an independent look, together with maturity and step-back.
At San.K.Bio Consulting, we will perform a thorough review of your CRAs’ monitoring reports, ensuring they deliver a high quality final report, that will give an accurate and clear picture on how the clinical study is handled at the site.
Because we believe on the importance of constructive criticism, we give advice and tips to the CRAs to improve the quality of their reports.