Сlinical study management (Phases I-IV)

Clinical study – is a study involving a human as the test subject for discovery or confirmation of clinical and/or pharmacological effects of the studied products and/or for detection of adverse drug reaction and/or for analyzing their absorption, distribution, metabolism in order to evaluate their safety and/or efficacy.

The main objective of clinical study is to evaluate safety and efficacy of a new drug.

Phases of clinical studies

  • Phase I. Objective: perform a clinical study in order to determine safety of the drug in healthy volunteer patients and/or their tolerance to it

Phase I– first trials of the drug substance performed in healthy volunteers (usually, about 12 volunteers per group and more). 

  • Phase II. Objective: perform a clinical study in order to find: an optimal dose of the medicinal product and treatment for patients with certain illnesses; optimal doses and vaccination schedules for healthy volunteers.

Phase II -  This phase is carried out in patients with specific illnesses or syndromes (about 30 patients per group and more). Efficacy and safety of the drug is tested in the presence of certain illnesses. 

  • Phase III. Objective: perform a clinical study in order to determine safety and efficacy of the drug product in patients with certain illnesses, as well as prophylactic efficacy of immunobiological drug products in healthy volunteers.

As a rule it is a comparative clinical study. Both original drug product (Generic drug studies) and reference/placebo drug/therapy can be used as a therapy in the control group.

III Phase clinical trials may be open (patient and trial team know what group the patient has been randomized to and what treatment he/she has been prescribed), blinded (disguised), Standard mask study – patient doesn’t know what group the patient has been randomized to and what treatment he/she has been prescribed, while trial team knows, Double mask study – neither patient nor trial team know what group the patient has been randomized to and what treatment he/she has been prescribed, Triple mask study – neither patient nor trial team or statistician know what group the patient has been randomized to and what treatment he/she has been prescribed, full mask study – all the participants of the trial don’t know neither patient nor trial team know what group the patient has been randomized to and what treatment he/she has been prescribed.

During phase III of the clinical study size of the groups is about 30-60 each.

  • Phase IV. Objective: perform a clinical study in order to reconsider indications, to detect previously unknown adverse effects of the tested drug product, conduct bioequivalence study or/and therapeutic equivalence study of generic drugs.

Post-authorization trial – trials that are carried out after drug product has been authorized in accordance with approved indications. The requirement for this study may be stated both by Ministry of Health of the Russian Federation and by Customer.

All over the world Clinical studies are an inseparable part of drug development process. In the course of clinical studies efficacy and safety of the product are tested. This information is very important for registration dossier, which is applied to the officials in the process of obtaining the license. 

«SOLYUR Pharmaceuticals Group» company has vast experience in organizing, managing and monitoring of clinical trials in compliance with National Standard of The Russian Federation (Good Clinical Practice) GOST Р 52379-2005, International guide for Good clinical practice (ICH GCP) and World Medical Association's Declaration of Helsinki, in accordance with federal law  N 61-FZ, dated April,12 2010  «On Medicine Circulation» Federal law № 429-FZ, dated December, 22 2014  «On amending Federal law  « On Medicine Circulation », in accordance with Order N 266 «On establishing of the rules of good clinical practice in the Russian Federation » , dated June, 19 2003. and with other regulatory documentation. 

We help our clients conduct registration studies of I, II and III Phase, which are necessary for licensing of drug products in the Russian Federation, as well as carry out IV Phase post-authorization trial and international multi-centre studies. We offer «end-to-end» management all stages from filing of documentation to presentation of Final report to the Customer, also we individually offer the following services:

  • Clinical trial feasibility studies and clinical development program;
  • Development of clinical study design (synopsis);
  • Determination of appropriate group size (number of patients) for clinical studies;
  • Production of main documentation for the clinical study (protocol, investigator drug brochure, patient information sheet, case Report Form);
  • Production of literature reviews for clinical studies;
  • Life- and health-insurance for volunteers/patients;
  • General liability insurance for researchers;
  • Document support and obtaining a permit from Ministry of Health of the Russian Federation for conducting clinical trials;
  • Selection and evaluation of potentially suitable research centers;
  • Transfer of clinical trial documentation, drug products and supporting materials to clinical centers;
  • Supervising of storage process and logistics in research centers;
  • Biosample logistics, temperature conditions preserved;
  • Monitoring of clinical studies (Revision at qualification, revision at initiation, revision at monitoring, final revision);
  • Preparation of research centers for Federal Service on Surveillance in Healthcare and Social Development of Russian Federation audits;
  • Preparation of Principal Investigator File and Main Trial File, as well as patients’ folders;
  • Cooperation with local ethics committees, filing and lodging of study documentation, obtaining permits from LEC for conducting of clinical trials;
  • Printing of files and folders for the study, self-copy Case Report Forms;
  • Assistance in development of individual digital registry card system;
  • Data management, development and maintaining of database;
  • Statistical processing of the results obtained by the end of the clinical trial;
  • Production of Final Clinical Study Report; 

Monitoring of all types of clinical studies

Clinical Monitoring System in our company is designed in accordance with ICH GCP, Legislation of the Russian Federation, profound internal SOPs and that’s why it guarantees:

  • Respect for patient’s rights and safety control;
  • High precision of obtained data;
  • Fulfillment of obligations to Sponsor. 

Clinical monitoring includes:

  • selection, opening and routine monitoring of the research centers;
  • Inspection of Regulatory Documentation;
  • Analysis of patient selection procedure and its compliance with exclusion and inclusion criteria;
  • Constant medical, technical and legal support of the centers;
  • Training and support of Research center staff;
  • Study Protocol Compliance Assessment Evaluation and obtained data coverage estimation;
  • CRF requests to research centers;
  • CFR checking, verification of data with initial documentation;
  • Principal Investigator File Checking and filing of all “logs”;
  • Recording and storage of all test substance;
  • Final revisions;
  • Production of monitoring reports;
  • Research Data Archives in research centers;