The Cutting Edge of Medical Technology Content, Community & Collaboration
Contract research organisation (CRO) is a fastest growing segment, provides support to pharmaceutical, biotechnology and medical device industries in the form of research services. The pharmaceutical companies can’t uphold and drop billions due to termination of patent and deficiency of new approvals. So they are approaching strategic alliances to sustain revenue and improve the product pipelines. These companies are increasingly outsourcing their R&D to CROs, which offer services that can increase R&D effectiveness and at lower costs. They also organises various services as preclinical research, clinical research, and clinical trials management along with pharmacovigilance and biopharmaceutical development process. Their credibility keeps on improving knowledge productivity and demonstrates tactics, will make customers becoming more demanding.
CRO identify five areas of innovation i.e. treatment of human subjects, control of disclosure, subjection of research tools to commercialization, redefinition of authorship, and re-engineering the goals of research. The worldwide business association for CRO i.e. association of clinical research Organisations (ACRO), employ more than 66,000 people worldwide. In 2008 ACRO member companies conducted more than 9,000 clinical trials globally, involving nearly 2 million participants, with research carried out in 115 countries. Data on clinical trials published in the Indian journal for medical ethics show an increase from 64 new trials in 2006 to 245 in 2010 and up to 787 in 2012, suggesting an 1100% increase in 6 years. Indian companies also increased their own clinical trials, testing new chemical entities of their own and entering into contracts with international companies. The growth in clinical trials activity allowed innovator companies to sponsor trials both directly and through contract research organisations.
In the past decade, the global spending on new drug development has been growing at an annual rate of 9.1%. However, the spending on contract clinical services has been growing nearly 50% faster at an annual rate of 13.4%. The requirement of new drugs and patent cliff are the key factors of contract manufacturing industry. Various parameters which governed CRO’s choice are information technology, culture, supply chain, experience and expertise.
Medical writing is a special wing of CROs. It mainly deal with different writing options across the clinical development phases, such as clinical research reports, manuscripts, patient information sheets, informed consent forms, study protocol and clinical study report. They also provide comprehensive services including data design, data entry and validation, data management and medicine and disease coding. The writing team structure ensures that there is always someone on hand to provide an independent quality control review of documents, so ensuring the quality and accuracy of deliverables. The independent reviewer in the team always ensures that nothing is missed and biostatistician reviews the clinical study report from a statistical perspective and ensures the credibility of reports.
WorkSure is an outsourced drug development services to pharmaceuticals industry, pharmaceutical research, biotechnology and medical device organisations. We offer a full range services like clinical data management, medical data management, pharmacovigilance & clinical study report preparation. We further provide comprehensive services including products, data design, data entry and validation. Our services are supported by in-depth therapeutic and regulatory expertise, graphic designers, medical writers, medical coders and biostatisticians.