On the stage of planning and preparation of a clinical study, study organizers need to develop a package of documents for registration of studies of therapeutic equivalence, bioequivalence or early phase clinical trials, as well registration and post-marketing studies.
Development of documents for clinical studies
“Certa Clinic” LLC has a great experience working in pharma industry and clinical studies, and provides services in development of documents for I-IV phase clinical trials including bioequivalence studies. Our specialists develop the following documents:
- Synopsis of a clinical study Protocol with calculation of a sample size;
- Investigator’s Brochure;
- Patient’s Information Sheet with informed consent form;
- Articles and literature reviews on a definite drug.
In our Clinical Center, a set of documents is developed by physicians having scientific knowledge in various therapeutic fields of medicine, as well experienced in development of a package of documents. While developing documents, physicians collaborate closely with biostatistics specialists.
Information required for development of clinical study documents:
Data on previous preclinical and clinical trials of a study product including own preclinical studies (for generics);
Draft instruction for medical use of a study product.
Protocol — the main clinical trial document containing study goals, aims, methodology and study conditions, description of enrolled population, examination and treatment methods, sequence of procedures, statistical methods of result processing.
Prior Protocol development, based on literature search and analysis of clinical trials of a drug, optimal endpoints are selected, sample size is calculated with regards to patient drop-off rate, design, study population, methods for statistical processing of results are briefly described, subject inclusion/exclusion criteria are set, schedule of procedures is formed.
Therefore a Study Protocol synopsis is made which after harmonization with the sponsor serves as a ground for writing a study Protocol.
Investigator’s Brochure — one of the main clinical trial documents representing a summary of results of previous preclinical and clinical trials of a study medicinal product. Investigator’s Brochure has a clearly regulated structure which describes general provisions, physical, chemical, pharmaceutical properties, provides data on preclinical studies, previous clinical trials, data discussion and instruction for medical use of a drug.
Aim of Investigator’s Brochure — provision of study investigators with all data on a study drug known to the current moment including its safety data. Investigator’s Brochure is revised periodically, new data is included in accordance with development stage of a study drug. Depending on completeness and quality of materials presented on clinical and preclinical studies, literature sources on a study drug can be individually sought.
If necessary, both documents obtained from a Client and found articles will be translated.
Patient Information Sheet with informed consent form — a uniform document representing two integral parts, signing which a study subject confirms in a written form his/her consent for participation in a clinical study giving consent and accepting all Protocol conditions. The document is developed based on a clinical study Protocol and contains study-related data in available form.
Case Report Form (CRF) — hard copy of a document or electronic questionnaire which is intended for collection of data obtained during a clinical part of a study for each study subject and is to be submitted to the Sponsor.
CRF development begins after finalization of a study Protocol.