Documentation development
The documentation preparation process is critical when obtaining a clinical trial permit, and also when demonstrating the results, which are crucial to continue developing and registering the drug.
Our team has extensive knowledge regarding the organization and compilation of documents for phase I-IV clinical studies, including therapeutic equivalence and bioequivalence studies, as well as biosimilars and new drug trials. The efficiency of documentation preparation is directly linked to our experts’ experience of creating final clinical study reports.
Our medical documentation and biostatistics specialists offer the following services:
- Preparing literature reviews on pre-clinical trials
- Developing clinical study programs
- Compiling expert conclusions based on available documentation
- Creating clinical trial protocol synopses with sample size calculation
- Creating clinical trial protocols
- Developing information leaflets for patients with consent forms
- Maintaining patient diaries and questionnaires for data collection
- Preparing responses to regulatory authorities’ requests
- Writing scientific papers and reviews
We strictly adhere to Russian and international standards, GCP, EMA, FDA requirements as well as internal company procedures. During the documentation development process, we collaborate with leading specialists in corresponding fields of medicine. All documents can be prepared in Russian and/or English.
Our employees regularly improve their qualification by participating in seminars conducted by regulatory authorities, which allow us to take into account both current and future requirements.
In cases when scientific data confirms it, we offer trial conduct with adaptive design, which allows us to simplify the medical substance development process, decrease the group size and reduce the trial duration and costs.
An adaptive design study allows us to modify its elements at the interim data level. This can include the alteration of inclusion criteria, randomization procedures, treatment strategies, sample size, concurrent therapies, procedure schedules, final points and statistical analysis methods. Typical examples include combined phase II – III trials and studies with amendment of the sample size based on interim data analysis.
If necessary, we also offer study documentation translation services. Our translators are carefully chosen and have all the necessary certificates and qualifications.