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.

ESSENTIALS OF MEDICAL WRITING

Professional medical writing involves communication of clinical and scientific data in the form of research and regulatory paperwork, articles for publication, in addition to content development for health-related publications, pharmaceutical companies and professional medical websites. The nature of medical writing varies using the need of the end user; for example documents regarding medical journals, physicians, individuals, pharmaceutical companies etc.

A capable Medical Writer must have good understanding of life science, medical and pharmaceutical terms along with proper knowledge of The english language. Qualities of a simple yet effective Medical Writer comprise of correct interpretation of target audience needs, better perception of project objectives, ability to prepare thoughts and deliver inside stringent timelines.

Medical writing gets started with appropriate literature seek and identification of reliable cause of information. In order to develop and frame an original work it truly is obligatory to apprehend the topic well by thorough literature review. Moreover, fact presentation in any scientific article is justified judging by genuine references, which makes literature search much more important.

Literature search ends up by having an unorganized pile of raw material which should be shaped and constructed in a order. There must be cohesion among sentences those must grow and count on each other, thus building logically correlated paragraphs. Such glued paragraphs are designed for conveying the medical author ideas effectively, whereas any non-cohesive mass of sentences leaves the reader mixed up and frustrated. The principle of cohesion with medical writing is that the sentences must provide linear move of information making file appealing and interesting for you to reader.

A careful selection in addition to elimination of data in addition to information from collected material is essential. A good medical writer should not stray from the subject. Content must be educational, well-constructed and correlated to hold the reader curious all through. A skillful assemblage of facts is necessary to guide the reader over the write up from what he knows as to the he wants to know in accordance to his needs in addition to expectations.

Medical Writer must allow you to assembling the draft inside a proper format, with apparent and precise explanation shown without ambiguity. Once a draft is prepared it truly is revised repeatedly to make it more comprehensible, communicative in addition to revealing. Medical writer should be capable of comprehend the prerequisites of varied types of articles one example is research article, original post, systematic review, brief record, editorial, case reports, in addition to letter to editor. Along with manuscript preparation, an effective Medical Writer should develop the skills to ascertain the high quality (based upon factors like impact factor and different indexes or rankings) and choice of journals. A clear check out of journal specific requirements is equally important. On top of that, medical writing includes prep of write ups regarding conferences; promotional items for marketing and sales team and training material.

Other attributes of your competent Medical Writer include presentation in the data in accordance for you to client’s requirement or predefined SOPs and most crucial of all is usually to avert plagiarism.
There is a significant need for efficient Medical Writers in drug companies, biotech organizations, nursing homes, contract research organizations (CROs) as well as other health communication agencies. The particular ever changing world of clinical and scientific study demands continuous propagation of technical knowledge. Medical writing is a compelling demand of contemporary scientific world.

WorkSure™ provides a wide range of high quality Medical Writing Services for pharmaceutical, biotech and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range of regulatory, clinical, scientific and marketing communication documents allowing you to focus on your core competency areas.