During recent years, a remarkable growth has been observed in the field of clinical research because of which clinical trials boomed in India. The increasing number of clinical trials has led to the hiring of the Contract Research Organizations (CROs) by various pharmaceutical, biotechnology and medical device industries. The CROs plays a very vital role in the management of the company’s clinical trials and provides support in the development of new drugs or medical devices. According to Good Clinical Practice: Integrated Addendum to International Conference on Harmonization or ICH-GCP (E6 1.20), a CRO is defined as “a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” CROs not only assist in pre-clinical and clinical trials, but also help in all kinds of post-marketing research activities and post-marketing surveillance. They may be a part of all the phases of the drug/medical device development process, and is responsible for a number of activities ranging from preparation of protocols to materials for submission to regulatory authorities. It is the key responsibility of a CRO that the data generated by CROs is unbiased and is not false or misleading. All the documents prepared should always meet the recent and updated regulatory requirements for approval and all the records should be accurate, properly maintained and are easily accessible for audit inspection. Further, a CRO should ensure that a clinical trial is conducted in accordance with the applicable regulations and Good Clinical Practice (GCP). All the developments and updates related to the clinical trial should be communicated with the sponsor in a timely manner.
One of the leading Clinical Research Organization (CRO) is WorkSure®, which is the first Medical Service Knowledge Process Outsourcing (KPO) in India has proved to be a reliable partner adding value to medical researches across the nation. It has constantly been setting new standards in the field of clinical research. It has a skilled work team with specialized knowledge in the field of medical and life sciences. The medical writers and clinical research executives of WorkSure® have knowledge of both writing and science, including scientific and clinical research processes. On behalf of a sponsor, a CRO can perform multiple tasks for speedy and smooth implementation of trials along with launch of new products like drugs and medical devices. The CRO services include pre & post clinical research, clinical trials management, pharmacovigilance, clinical data management, biostatistics and training & development. In addition to sponsor companies, WorkSure® assists numerous research institutions, universities, NGOs and government organizations. Further, it provides services involving medical writing and statistical analysis of data obtained from clinical trials. Further, it takes care of all the documents to be prepared for regulatory submission such as Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND), New Drug Application (NDA), and Periodic Safety Update Report (PSUR). In short, WorkSure® has end to end solutions for medical writing, clinical research training and site development along with clinical data management (CDM) for all pre-clinical, medical and clinical studies.
