Introduction
Clinical research organizations, also mostly referred as contract research organization (CRO) are organizations that offer research services pertaining to pharmaceutical, medical device and pharmaceutical companies. It supports pharmaceutical and biotechnology industries through outsourcing pharmaceutical research services. Primarily, on the basis of services and timeline, Clinical research organizations are of four types, i.e., Discovery, preclinical, clinical, laboratory services.
How do CROs work?
Clinical research organizations undertake clinical trials and research support services for many organizations, pharmaceutical industries, biotechnology, government and foundations. They are responsible for planning, strategizing and management of clinical trial so contracted. It is of significance that these organizations adhere to Good Clinical Practice. Some of the services include:
Project management: it includes procedures, logistics and resource allocation management
Data management: it includes database design, data entry and validation, database maintenance and archival, security procedures.
Clinical study management: it is inclusive of site recruitment, patient recruitment, study monitoring, site management.
Research compliance: it includes audits/FDA Inspection support.
Research education: it includes clinical SOP Development and GCP Seminars
Medicine and Disease Coding
Validation programming
Product development planning: it includes market assessments, research, strategic planning Consultation, Medical Product Registration
Product commercialization: it includes market research, product launch, product marketing, product sales.
Safety and efficacy summaries
Quality reporting
Biostatistics: it includes CRF review, Statistical Methodology Consultation and Statistical Analysis Plan Development
Statistical Analysis Reports
Final Study Reports
Medical Writing: it includes Clinical Study Protocol Documents, manuscripts, posters, PowerPoint presentations, white papers.
Top 10 Clinical Research Organizations in India:
1. Analytica Chemie:
This company manages clients from three different sectors i.e., pharmaceutical, food and analytical testing industry. It deals with the quality reference standards in addition to analytical data and aid the regulatory compliances. It is one of the first companies to commence a laboratory for the synthesis of pharmaceutical impurities and standards in India. Till date, they have synthesized and supplied more than 8000 impurities standards and maintained a stock of most of the commonly required impurities.
2. Bioneeds:
This company is leading in the field of preclinical Clinical research organizations and has been offering integrated discovery, development and regulatory services to its clients. It deals with the pharmaceutical, herbal, industrial chemical, biopharmaceutical and medical device industries. They have specialization in drug testing like DMPK, pharmacology, toxicology, bioanalytical, alternative to animal studies and invitro. The company was also engaged in screening of many covid-19 drugs and vaccines.
3. Dabur Research Foundation:
It is an Indian CRO which provides pre-clinical service in the areas of drug discovery and development, ranging from identification of potential lead molecules, IND enabling studies and drug development. Established in 1979, it has conducted more than 100 NON-GLP and 700 GLP studies. Its services are pertaining in the field of In Vitro, Ex-Vivo, and In-Vivo Pharmacology, Exploratory & GLP Toxicology & DMPK.
4. Genext Genomics:
One of the emerging companies, Genext Genomics is offering purpose-based solution for life science customers since 2011. It is specialized in in depth research in drug discovery services. It has built a strong platform for development of antibodies and is driven to meet the healthcare solutions for the country.
5. George Clinical:
the company has expertise in therapeutic areas like kidney, metabolic, oncology, chronic and cardiovascular diseases and conducts clinical trials for the same. It has already undertaken clinical trials during COVID-19. The company has reached heights due to the cohesive and committed global team which offers end-to-end services and scientific driven operational expertise. It includes services ranging from helping design a clinical trial to submission of the report to regulatory authorities. They also offer client specific services such as clinical monitoring, medical monitoring, data management and others.
6. ICBio:
Emerged in 2008, the company is listed among the top 10 Clinical research organizations of India. It provides comprehensive, quality & integrated data and clinical trial solutions. It also includes clinical trials and clinical endpoint studies. The company offers services to industries specialized in pharmaceuticals, personal care, cosmetics, OTC products, nutraceuticals, medical devices and herbal companies. The company also consists the latest ICP-MS Bio analytical instrument offering the sensitivity to conduct hormone studies, etc.
7. United chemical laboratory:
Based in India, the CRO aims to offer high quality and reliable research and testing services in the area of product safety assessment. It is specialized in creating, analyzing and conducting toxicology, chemistry, ecotoxicology, environmental fate studies.
8. QPS:
QPS is famous for its quality standards,, flexible approach of researching, client satisfaction and turnkey laboraroites.it provides services in neuropharmacology, DMPK, toxicology, translational medicine, bioanalysis, clinical development.
9. Raha life sciences:
The CRO is engaged in clinical research and offers services in the field of allopathic, Ayurveda, homeopathy, nutraceuticals, medical devices.
10. Ultra-pure analytics india:
based out of Mumbai, the CRO offers solutions leveraging latest technology to deliver isolation, chemical characterization, purification and HPLC method development services to leading pharmaceutical companies.
Is it better to work for a CRO or pharmaceutical company?
Big pharma companies are renowned for their team environment and have specific goals to fulfil. They are equipped with cutting edge technology and are backed with scientific excellence. Unlike Clinical research organizations, many big pharma companies offer better remuneration. Further, they are more stable than Clinical research organizations. However, being big companies, they are usually viewed as conservative ad stodgy. The work environment tends to become more conservative. On the other hand, Clinical research organizations provide a diversity of work, variety of experiments and trials. These organisations also offer opportunities for work from home. The employees are further trained to broaden the skillset. Sometimes, they are compensated for the extra hours of efforts they have put into.
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