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.

Risk Evaluation and Mitigation Strategies and Risk Management Plan part II

Risk Management Plan part I
Document important for the submission of REMS contain patient package insert, communication prepare, elements to assure safe make use of, (ETASU) implementation system if ETSAU included, timetable for submission of review. EU- Risk Management Plan consists of three important elements – a. safety information of the item known through studies, b. pharmacovigilance plan which details about handling of uncertainities c. Risk minimization plan which indicates measures that will probably be taken to reduce the consistency of known risks.

Each drug with Risk evaluation and management strategies is listed within the specific database of the regulatory for monitoring end-to-end program execution. Validation of registry with scientific data (patient, physician, hospital, and pharmacy data) is vital for risk monitoring and assessment of program effectiveness with the patient and provider.

The EUROPEAN UNION RMP is more comprehensive, more extensive and contains wider scope than the US REMS on account of binding on a large list of medicines. The US REMS is compulsory for many medicines only, and can be limited by two years post product launch but also in EU the sponsor is obliged to follow throughout the lifecycle of new drugs or biologics.