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According to PMBoK (Project Management Body of Knowledge), a project is a “temporary endeavor to create a unique product, service or result”.
A clinical trial of a medicine or medical device should be considered as a complex and large-scale project that requires a multifunctional and well-coordinated team.
A clinical trial, like any other project, consists of a large number of various components and is carried out in several stages:
A well-controlled clinical trial begins with a clear identification of possible risks and proper project planning to reduce the likelihood of these identified risks and minimize their consequences. It is crucial for the success of the entire project that the project team has a profile expertise in the selected therapeutic area of the investigational medicinal product or medical device.
Based on our track record of successfully completing over 340 phase I–IV trials in over 25 different therapeutic areas, a potential client can rely on the high-level professionalism of the Synergy’s project team and our deep understanding of all the nuances of the planned study and expected indications of investigational medicinal product / medical device. Our team knows how to find the most effective approaches and solutions in searching for suitable clinical sites and recruiting the required number of necessary categories of patients.
Strength of Synergy is deep knowledge of the regulatory legal acts of the Russian Federation, the Eurasian Economic Union and CIS countries and local medical requirements for the examination and treatment of various population groups. We guarantee our clients that our project teams have dedicated expertise and a high competence in performing study of any phase according to the therapeutic area of investigational medicinal product / medical device. Our project team will assist you with project budgeting and planning, medical writing, study approval, monitoring, auditing, vendor management, and will provide necessary consultations with key opinion leaders and experts and interaction with regulatory authorities throughout the study.
From the beginning to the end of a study it will be managed by dedicated, focused project manager, who is aimed to build synergistic relationships with all study participants through clear communications, decisive escalation of issues and coordination of decisions and actions.
The expertise and experience of Synergy’s project managers ensure the successful and timely conduct of complex, multi-center, international clinical trials as well as local single-site bioequivalence studies.
The strong knowledge of national peculiarities of the countries of Synergy presence provides a client with the opportunity to easily select and establish constructive and mutually beneficial relationships with a diverse group of local vendors engaged in the conduct of the planned clinical study.
Utilizing simple and effective Standard Operating Procedures (SOP) with a solid proactive and solution driven conviction, Synergy’ project managers will guide client’s study safely and effectively to its completion, ensuring quality deliverables on time and within budget and in accordance with protocol, client’s policies, applicable regulations and scientific guidelines.
There could not have been better news for today! Thank you very much for your precious support during the submission process and also for the exceptional work to receive only one short comment from RA to the whole package. Please forward my special thanks to your whole team! I am looking forward to continuing our work on this study.