Medical Writing Services
Medical writing pertains to conveying data and information that is either scientific or clinical, to a wide array of audiences which can be presented in a diverse range of formats. With a shift in focus to research and development, a large number of pharmaceutical organizations are engaged in the process of developing new drugs and are conducting extensive clinical trials. This has led to an increasing need for submitting documents to regulatory authorities. This warrants the need for medical writing. Thus, medical writing is of utmost importance in the scientific and clinical domain. The manner in which medical information is conveyed can make the difference. But most pharmaceutical and clinical research organizations are more equipped to focus on drug development or clinical research. This proves to be a challenge as they are not equipped to execute the medical writing aspect which is mandatory. In case they have the know-how to execute the medical writing process, they are faced with time constraints that prevent them from documenting the information.
reknowly offers medical writing services that are designed to cater to the specific needs of pharmaceutical and clinical research organizations. We facilitate our clients by extending them with adequate help in their scientific, clinical, regulatory writing and enable them to create educational materials as well as scientific communications. The scope of medical writing services we provide is extensive and can have far reaching implications on the outcome of their research.
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To extend medical writing services we adopt an integrated approach where we ensure that there is an amalgamation of research skills and scientific knowledge. This combination is enhanced further when the medical writer has the know-how pertaining to the manner in which the information is to be presented while pitching it at the right level to the target audience. The target audience in this case would refer to the scientific community or the regulatory body. This unique approach towards medical writing helps us to create content that is valid, authentic, meets the specific guidelines as laid down by regulatory authorities. It also makes a definite impact on how the outcomes of the clinical research is outlined and presented to the scientific community at large.
Under medical writing services we offer diverse solutions that is bifurcated into two sections; which would include
Clinical and Regulatory Writing
- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR synopsis for public disclosure
- Study Protocols
- Brochures for investigators
- Brochures for patients and documentation that outline informed consent and patient information
- Narratives that outline patient safety
- Periodic safety update reports that are specifically used in pharmacovigilance
- SOPs that encompass every facet in the process of drug development which includes; design and conducting and reporting clinical trials.
- Conference materials (slide sets, abstracts, poster presentations)
- Joural / Conference Submission
- Editorial support services
- Product documentation (for patients and scientific audience)
- Medical marketing reports and reviews
Medical and Publishing
reknowly partners with you to extend the entire gamut of medical and publishing services. The unique approach we adopt to extend medical and publishing services encompasses; literature search, data collection, extensive medical processing, exhaustive strategies, medical reviews, analysis and reporting. The relationships we establish with our clients on the basis of this service stands testimony to our reliable and trustworthy services.
With our bio-statistical services, we enable clients to further their research programmes through clinical research stages. We facilitate clients to conduct statistical analysis within their phase II-IIIb trials. Our bio-statistical services offer inputs within trial design, structure intricate plans for statistical analysis and enable sponsors during the process of regulatory filing.
The style of writing adopted by our annual report writing services experts is such that it is at par with international standards.View Our Portfolio
- Single Point Contact: We connect clients with the right personnel who fully understand their requirements and deploy their expertise and know-how in delivering the medical writing services. This ensures that there is no ambiguity or any confusion while executing the project.
- Compliance with International Standards: Medical writing services that we offer comply with international standards and are written while adhering to regulatory requirements.
- Domain Knowledge: Experts at reknowly have ample domain knowledge with regards to clinical research. They are well aware of the complexities of clinical research and understand the need for precise writing that add value to the research outcomes and is accepted by regulatory authorities.
- Attention to Detail: Medical writing services that we extend ensure that even the minute details are taken into consideration. This is particularly beneficial as no aspect of the research is omitted and the writing takes everything in its ambit.