Medical Writing Companies: Rethink knowledge through collaboration

Medical writing and clinical data management has seen an extensive growth in India these days due to active involvement in the medical and clinical research activities. A number of Contract Research Organizations (CROs) have come into picture that provides its services to multiple healthcare organizations. The medical writing services include preparation of a diverse range of clinical research documents that are required by the stakeholders, including clinical investigators, Institutional Review Boards (IRBs), study coordinators and regulatory reviewers. They also prepare and provide manuscripts that are concise, accurate and are ready for submission to peer-reviewed medical journals for publication. The medical content is prepared according to the needs of the end users that can be physicians, healthcare organizations, pharmaceutical companies, biotech companies, etc.

For an effective propagation of knowledge from a lab where experiments for a particular study are conducted to the people, medical writing is an essential tool. The knowledge can be conveyed through multiple forms such as publications, newsletters, blogs, websites and pharma-healthcare magazines. One of the important goals of a scientist or clinician is to publish their original research in a peer-reviewed and indexed journal that can lead to the recognition of their novel scientific work. However, the lack of technical and writing skills, institutional hurdles, and time constraints can pose a challenge to the researchers. Due to the linguistic and technical constraints faced by researchers, there have been the growth of medical writing companies that can be contacted for collaboration.

Read more at https://bestmedicalwritingservices.blogspot.com/2021/06/medical-writing-companies-rethink.html

medical writing, medical manuscript preparation, Contract Research Organizations

Clinical Research Organization – WorkSure

WorkSure is a Clinical Research Organization. Since its formation we have been offering drug and device development services to pharmaceutical and bio technology companies worldwide. Our focus allows us to be at the forefront of the field and to help our clients pass their product through the testing and regulatory process in a rapid and cost-effective manner allowing them to market their drug and devices faster.

At WorkSure, quality is a state of mind. Our Quality Assurance program is designed to ensure that your studies are performed in compliance with requirements, guidelines and local regulatory laws.

WorkSure Expertise

With a track record working with industry leaders, mid-size and start–up companies, WorkSure supports its client’s in preclinical and clinical research projects with a wide range of specialized study services. From bench-formulation and research through to phase IV studies and marketing surveys, our experienced staff have an excellent knowledge and know-how of each step of the drug development as well as a global overview of the whole process. At every stage of our client’s projects we are able to conduct studies that meet their specific needs and objectives. We also provide accurate consulting services at every stage of drug development to help our clients to anticipate and plan for any issues which may arise during the drug development process.

WorkSure Consulting Services

WorkSure MedPharma Consultancy provides the required understanding and experience to guide your new products through the development process. As a partner we help to direct preclinical and clinical drug development, to anticipate and plan for any issues which may arrive, to design and manage drug and device development programs, or to provide strategic study design.

WorkSure Drug Development Process

Before any clinical trial can begin, the researchers must file an Investigational New Drug (IND) application with the FDA. The application includes the results of the preclinical work, the candidate drug’s chemical structure and how it is thought to work in the body, a listing of any side effects and manufacturing information. The IND also provides a detailed clinical trial plan that outlines how, where and by whom the studies will be performed.

The FDA reviews the application to make sure people participating in the clinical trials will not be exposed to unreasonable risks.

Phases of Clinical Trial

Clinical Trial is divided in three phases.

Phase 1 trial the candidate drug is tested in people for the first time. These studies are usually conducted with about 20 to 100 healthy volunteers. The main goal of a Phase 1 trial is to discover if the drug is safe in humans.

Phase 2 trials researchers evaluate the candidate drug’s effectiveness in about 100 to 500 patients with the disease or condition under study, and examine the possible short-term side effects (adverse events) and risks associated with the drug.

Phase 3 trials researchers study the drug candidate in a larger number of patients to generate statistically significant data about safety, efficacy and the overall benefit-risk relationship of the drug. This phase of research is key in determining whether the drug is safe and effective.

Once all three phases of the clinical trials are complete, the sponsoring company analyzes all the data. If the findings demonstrate that the experimental medicine is both safe and effective, the company files a New Drug Application (NDA) with the FDA requesting approval to market the drug.

Medical Communications is crucial for improving clinical care

Medical communication is the process of sharing medical education between pharmaceutical companies, physicians and other healthcare professionals. It plays a vital role in raising awareness of medicines. Medical communication is essentially carried out by medical communication agencies. Medical communications agencies are also referred to as medical education agency or ‘MedComms’ agency.

WorkSureTM, a medical communications agency, offer expert consultancy services to the pharmaceutical companies by suggesting measures for dissemination of clinical data, providing guidance on how to educate their customers about new therapies and organizing campaigns for drug promotion. Medical communications also help to devise risk management strategy (REMS/RMPs) for a pharmaceutical company. Medical communication agencies are contacted by pharmaceutical companies for preparation of documents like Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) etc. Physicians get complete information about the products with the help of these documents. Furthermore WorkSureTM also assist in preparation of a wide range of scientific documents like journal manuscripts for peer review, slide kits, posters and presentations for conferences.

Communication failure is one of the major reasons responsible for adverse clinical events and consequent claims of negligence. The role of medical communication is therefore crucial for best clinical care of patients. Nowadays, medical communication is practiced highly in medical institutions and health research centres. Doctors can also play a major part by sharing important with colleagues, nurses, and other staff in the hospital and share information. WorkSureTM is running FMRC programme to promote medical research and communication in the country. We also do other educational programmes on Medical/Clinical research methodologies