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Medical writing requires an in-depth understanding in medical science and thorough knowledge of specific requirements towards the treatment and examination of definite groups of patients as well as keeping up to date with the appropriate regulatory guidelines.
We know how to prepare a complete package of high quality study specific documents comprising:
We have been providing high quality medical writing services since 2010. Our team of medical writers is made up of industry professionals who have experience in practical medical work along with extensive expertise in preparing the ICH GCP (International Council for Harmonisation – Good Clinical Practice) essential study documents, study reports and scientific publications.
Synergy’s medical writers collaborate closely with biostatisticians, regulatory support and clinical operation specialists to create consistent, scientifically cohesive documents in accordance with modern scientific guidelines, ethical principles and applicable regulatory requirements.
Over 20 years of work, we have seen that the design of any clinical trial is more important than its results analysis. A poorly designed study can never be recovered, whereas poorly analyzed study with evidence-based and high-quality design can be reanalyzed to reach an unambiguous and convincing conclusion.
In other words, the design of the study decides how the data generated can be best analyzed. The scientific integrity of the study and the credibility of the data from the study thus substantially depend on the study design.
When designing a study protocol, our medical writers start by clearly defining and understanding, what is the defined population from which groups of subjects are studied and what are the outcomes that are measured. This in turn supports our clients to reach the desired target indicators for the investigational medicinal product.
Synergy’s team of medical writers has extensive and in-depth experience in developing various types of protocols for phase I–IV clinical trials, observational, and bioequivalence studies in different therapeutic areas. A wide range of medical organizations and investigators with whom the company collaborates in the field of clinical research allows a preliminary remote feasibility assessment of launching and conducting certain studies in individual clinical sites.
Clinicians make a significant contribution to the preparation of the study protocol, providing exact and practical advice regarding patient selection criteria, optimal treatment regimens and examinations of selected patient categories. The above mentioned data, along with information on the subject recruitment rate, allows not only to plan studies well, but also to prepare a more accurate budget of the planned clinical trial.
To-date Synergy is proud to share with both our existing and potential clients that we have not received a single rejection from a regulatory authority for medical writing reasons.
I would like to once again thank you for the great work! The report has been completed successfully.
(translated from Russian)