LOADING
Selecting study sites using our proprietary database of over 1,000 medical institutions (study sites) and more than 3,000 investigators.
Accurate, realistic and understandable calculation of a viable clinical trial budget and financial plan. We have mastered the art of budgeting and financial planning for projects in our native industry.
We know how to prepare a realistic and viable financial plan for a clinical trial of any complexity, in order to help the Sponsor accurately and thoroughly define all the necessary specifications, options and nuances of the project, and receive information from all vendors, suppliers, clinical sites and partners (including foreign ones) involved in the project. Without forgetting a single thing, we will achieve the top quality level of services at the best price, and present the final calculation result in a clear, simple and understandable form.
Also, we can calculate the project budget for a large-scale international multicenter clinical trial by involving our foreign partners (members of the international alliance ACROSS Global Alliance) from 102 countries of the world.
Developing, reviewing and finalizing the clinical trial documents (protocol, investigator’s brochure, subject information sheet with informed consent form and final report on the conducted clinical trial of a medicine / medical device).
Assessment of possible regulatory risks and scientific advice; submission of a clinical trial application and obtaining clinical trial approval by regulatory authorities in the Russian Federation and in the EAEU and CIS countries.
Effective start and execution of a clinical trial project in accordance with the best industry practices and methodologies (PMBoK, Agile, F.A.S.T.).
Organizing and conducting clinical monitoring, including on-site monitoring visits to study sites, remote monitoring, management of study sites and centralized monitoring using a risk-based approach.
Involving the personnel with dedicated qualifications to resolve study-related medical issues.
Preparing a data management plan for a clinical trial, data validation using an Electronic Data Capture (EDC) or paper-based record keeping (CRF).
Calculating the required sample size, preparing a statistical analysis plan and statistical report on the completed clinical trial.
Selecting vendors providing services, materials and systems for a clinical trial project and organizing a full cycle of work with them, including the logistics of laboratory materials and clinical trial materials (including biological samples).
Each clinical trial requires a variety of operational tasks, and for some of these we rely on third-party providers of services, materials, and systems. Choosing the right provider is for sure critical to the success of a clinical trial.
We approach this issue with the utmost care and work only with trusted companies that provide services and supplies of the highest quality materials and solutions, whether it is a central laboratory, a company supplying drug(s) and clinical trial materials, a repository for storing biological samples, IT service provider or translator.
When choosing a vendor, we primarily focus on the experience of successful work in clinical trials, the availability of a built-in quality management system, the vendor’s presence in the regions of our company’s operations, as well as the services cost.
Planning and conducting clinical trial audits, preparing for audits by the Sponsor or regulatory authorities, including Roszdravnadzor, the Food and Drug Administration (FDA, USA) and the European Medicines Agency (EMA).
Concluding contracts and executing financial settlements with study sites and investigators.
Since the beginning of 2019 we have prepared and processed more than 2,000 payments for a total amount of more than 500 million rubles.
Timely and accurate payments to investigators are of particular importance not only in relation to the fulfillment of contractual obligations, but also to maintain the motivation of study site staff and increase their efficiency.
Our financial managers make payments to investigators and study sites for all projects conducted by Synergy. These payments include not only payments under the clinical study agreement, but also payments to doctors who refer patients from other medical institutions to clinical sites for possible participation in the study, for consulting services, for reports presentations made by investigators, for the participation of specialists from different areas in the Independent Data Monitoring Committees’ meetings.
Our financial managers have more than ten years of experience in the company and have broad competencies that allow them to promptly resolve any emerging issues.
Registration services for medicines and medical devices in accordance with the requirements of local regulatory authorities, including Roszdravnadzor (Russian Federation), EAEU and CIS countries.