High-quality medical writing is an integral part of a successful clinical trial. It is well-crafted documents and a well-thought-out scientific approach that ensure compliance with regulatory requirements, accurate data interpretation, and ultimately, the successful registration of a medicinal product.
OСT offers a full range of scientific consulting and medical writing services, drawing on over 20 years of experience in the industry and participation in 300+ projects at various stages.
The employees of the MedSci Consulting and Excellence department are professionals with expert knowledge in biostatistics, clinical development, regulatory requirements, and scientific publications, and they have experience in various therapeutic areas. OСT specialists are active members of the European Medical Writers Association (EMWA), which confirms their high level of qualification and continuous professional development. All documents developed by our medical writers meet the requirements of both local and international regulatory bodies.
Proper study design is the foundation for obtaining reliable results and successfully bringing a drug to market. Our approach includes a thorough analysis of the study goals, consideration of potential risks, and the development of a strategy that will ensure the achievement of the expected results while complying with all regulatory requirements.
Accurate calculation and justification of the sample size is another important stage of study protocoling. OСT specialists use modern methodologies and software to determine the optimal number of participants, which allows for the minimization of costs and the avoidance of errors in the interpretation of statistical data.
Documents submitted to regulatory authorities must be flawless. OCT professionals prepare a complete package of regulatory documentation, including protocols, Investigator’s Brochures (IBs), clinical trial reports, safety and efficacy summaries. All materials comply with the requirements of the EAEU, ICH, and other international standards, which significantly reduces the time it takes to obtain approval.
Preparing scientific articles, abstracts, and materials for conferences is another important area of the company’s work. We help transform research data into high-quality publications that meet the requirements of leading international journals and scientific events.
Medical writing and scientific consulting are not just about preparing documents, but a strategically important part of clinical development. By partnering with OСT, you gain a reliable partner capable of ensuring a high standard of quality, transparency of processes, and accuracy in every detail.
If you are interested in services for developing a clinical trial protocol, managing medical documentation, or writing a scientific article, contact the experts at OСT to receive a free consultation and development of a customized proposal tailored to the goals of your project – info@oct-cro.com.
