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Volume 11, Issue 1
  • ISSN: 2667-3371
  • E-ISSN: 2667-338X

Abstract

Contract Research Organizations are bodies that offer research and development services on a contract basis to the pharmaceutical, biotechnology, medical device, and other industries. These organizations offer a wide range of services to support the drug discovery, development, and commercialization process. Initially, CROs begin with clinical trial management facilities and assisting sponsors with clinical study design, whereas laboratory CROs provide drug discovery, manufacturing, and bioanalytical services, including site feasibility. Their services mainly cover pharmaceutical and biotechnology industry based work such as drug development, pharmaceutical product development, clinical and preclinical trials, analytical method developments, pharmacovigilance, medical writing, . India presents itself as a wonderful platform for CROs attributing to its huge population, varied disease conditions, accessible human resources, large number of hospitals and low treatment cost. In the clinical trial process, CROs are engaged by the sponsor to accomplish a number of duties, taking into account various administrative and technical responsibilities on behalf of the sponsor. The current manuscript highlights the globalization of clinical trials, the concept of CRO, roles and responsibilities, functions of CROs, regulatory infrastructure of CRO, criteria for selection of suitable CRO, Indian CRO market and impact of COVID-19 pandemic on it.

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2024-12-10
2025-06-26

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References

  1. MullinR. The changing landscape for contract research organizations.Chem. Eng. News201795221719
     [Google Scholar]
  2. GetzK.A. WengerJ. CampoR.A. SeguineE.S. Assessing the impact of protocol design changes on clinical trial performance.Am. J. Ther.2017243e361e372
     [Google Scholar]
  3. LaMattinaJ.L. The impact of mergers on pharmaceutical R&D.Nat. Rev. Drug Discov.201110855956010.1038/nrd3514
     [Google Scholar]
  4. MoatJ. The evolution of CRO and sponsor relationships.Appl. Clin. Trials20233211110
     [Google Scholar]
  5. DiMasiJ.A. ReichertJ.M. FeldmanL. Clinical trial success rates 2006-2015.Clin. Pharmacol. Ther.20211093799806
     [Google Scholar]
  6. NestorM. PariserD. RossoJ.D. GlaserD.A. GoldbergD. Ablon, G., Lorenc, Z.P. Santos J. The Future of Contract Research Organizations in Dermatology and Aesthetic Research.J. Clin. Aesthet. Dermatol.20221591619
     [Google Scholar]
  7. ShihM-S. Roles of contract research organizations in translational medicine.J. Orthop. Translat.201532858810.1016/j.jot.2015.01.001
     [Google Scholar]
  8. BhattA. Future of Indian clinical trials: Moving forward from hyped potential to human protection.Perspect. Clin. Res.2017812410.4103/2229‑3485.198553
     [Google Scholar]
  9. MathewS.S. PatelG.P. An overview of contract research organization and analysis on aco-cro model.J.Pharm. Sci. Res.201911520122015
     [Google Scholar]
  10. KandiV. VadakedathS. Clinical Trials and Clinical Research: A Comprehensive Review.Cureus2023152e3507710.7759/cureus.35077
     [Google Scholar]
  11. GambleC. KrishanA. StockenD. LewisS. JuszczakE. DoréC. WilliamsonP.R. AltmanD.G. MontgomeryA. LimP. BerlinJ. SennS. DayS. BarbachanoY. LoderE. Guidelines for the content of statistical analysis plans in clinical trials.JAMA2017318232337234310.1001/jama.2017.18556
     [Google Scholar]
  12. Dimachkie MasriM. RamirezB. PopescuC. ReggieE.M. Contract research organizations: an industry analysis.Int. J. Pharm. Healthc. Mark.20126433635010.1108/17506121211283226
     [Google Scholar]
  13. HaleG.A. PullumJ. Clinical Research Organizations.Pediatric Cancer Therapeutics Development. Pediatric Oncology. DiMartinoJ. ReamanG.H. SmithF.O. ChamSpringer202210.1007/978‑3‑031‑06357‑2_8
     [Google Scholar]
  14. Arora NageenA.N. AroraN. KhattarH. KaulP. GoelT. Contract resraech organzation and its growth criteria.IOSR J. Pharm.20122218218310.9790/3013‑0220182183
     [Google Scholar]
  15. ArnoldJ. HaydenD.M. Role of contract research organizations.The clinical research process in the pharmaceutical industry.CRC press1983
     [Google Scholar]
  16. ReddyC.D. GuptaN.V. Overview on contract research and manufacturing services (crams) and its present status in India.Asian J. Pharm. Clin. Res.2013623337
     [Google Scholar]
  17. PattarG. The role of contract research organization.Available from:https://youngmdconnect.com/articles/2023-apr/the-role-of-a-contract-research-organization(accessed on 23-10-2024)
  18. GodS.C. Contract Research organizations.Encyclopedia of toxicologyElsevier202410.1016/B978‑0‑12‑824315‑2.00830‑7
     [Google Scholar]
  19. VillanuevaA. Contract research organization and their role in medical innovation.2023Available from:https://www.outsourceaccelerator.com/articles/contract-research-organization/(accessed on 23-10-2024)
  20. MataR.C. CardesaA. LoraF. Good clinical practices in nonprofit institutions.Guide to cell therapy GxP.Academic Press201617722910.1016/B978‑0‑12‑803115‑5.00005‑X
     [Google Scholar]
  21. ICH E8 (R1) General Considerations for Clinical Trials.Available from:https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline(accessed on 23-10-2024)
  22. ICH E2E Pharmacovigilance Planning.Available from:https://database.ich.org/sites/default/files/E2E_Guideline.pdf(accessed on 23-10-2024)
  23. VennuV. DahiyaS. Awareness and Opinions of Research Professionals on India’s New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study.JMIR Res. Protoc.202091e1474410.2196/14744
     [Google Scholar]
  24. ChauhanP. MendoncaM. Role of regulatory authorities on the working of contract research organization and pharmaceutical company’s clinical trials in India: a study of strategic alliances between pharmaceutical companies and clinical research organizations in India.Asia Pacific Journal of Health Management2021163879110.24083/apjhm.v16i3.961
     [Google Scholar]
  25. Top 17 Clinical research organizations (CRO) in 2023.2023Available from:guides.clarahealth.com/top-clinical-research-organizations/(accessed on 23-10-2024)
  26. Leading global contract research organizations (CROs) based on 2023 revenue.2023Available from:https://www.statista.com/statistics/732804/top-clinical-research-organizations- -revenue/(accessed on 23-10-2024)
  27. Top 10 CROs to watch in 2024.2024Available from:https://www.proclinical.com/blogs/2024-5/top-10-cros-to-watch-in-2024(accessed on 23-10-2024)
  28. Labcorp. News Release Details.Available from:https://ir.labcorp.com/news-releases/news-release-details/labcorp-awarded-forrester-research-2023-customer-obsession(accessed on 23-10-2024)
  29. Santosh KumarR. PaulS. Contract research organization (CRO): An important partner to biotechnological and pharmaceutical companies.J. Drug Deliv. Ther.201994-A75976110.22270/jddt.v9i4‑A.3481
     [Google Scholar]
  30. Top 20 CROs: A comprehensive guide to the top 20 contract research organizations.Available from:https://www.lindushealth.com/blog/top-20-cros(accessed on 23-10-2024)
  31. Top clinical research organization for oncology.2024Available from:https://www.precisionformedicine.com/blog/top-oncology-cros-in-2024-and-beyond(accessed on 23-10-2024)
  32. RobertsD.A. KantarjianH.M. SteensmaD.P. Contract research organizations in oncology clinical research: Challenges and opportunities.Cancer2016122101476148210.1002/cncr.29994
     [Google Scholar]
  33. WasanH. SinghD. ReetaK.H. GuptaP. GuptaY.K. Drug development process and COVID-19 pandemic.Indian J. Pharmacol.202254536437210.4103/ijp.ijp_318_22
     [Google Scholar]
  34. Syneos Health Accessed.2024Available from: https://en.wikipedia.org/wiki/Syneos_HealthAccessed(accessed on 23-10-2024)
  35. Visser-RogersJ. Creating strategic relatioships: The changing face of contract research organizations and sponsor partnerships.Appl. Clin. Trials20232023110
     [Google Scholar]
  36. GlimoreD. Harmonizing outsourcing to keep clinical trials on track.Appl. Clin. Trials202332111214
     [Google Scholar]
  37. Contract Research Organization (CRO) Market Analysis North America.Available from:https://www.technavio.com/report/contract-research-organization-cro-market-industry-analysis(accessed on 23-10-2024)
  38. StrausM. CRO update: Where are contract research organizations headed?Appl. Clin. Trials20223131823
     [Google Scholar]
  39. BahlsC. In focus: Amid heightened industry rules on sustainability, how are CROs faring?Appl. Clin. Trials202433667
     [Google Scholar]
  40. Global Contract Research Organization (CROs) Services Markets.Available from:https://www.globenewswire.com/en/news-release/2024/02/26/2834914/28124/en/Global-Contract-Research-Organization-CROs-Services-Markets-2023-2029-Burgeoning-Opportunities-with-the-Emergence-of-Hybrid-Models-with-CRO-CDMO-Partnerships(accessed on 23-10-2024)
  41. Global Contract Research Organization Market Overview.Available from:https://www.marketresearchfuture.com/reports/contract-research-organization-market-3322(accessed on 23-10-2024)
  42. Thermo Fisher Scientific Named “Best Vaccine CRO” at Vaccines World Asia Congress.Available from:www.ppd.com/news-item/thermo-fisher-scientific-named-best-vaccine-cro-at-vaccines-world-asia-congress/(accessed on 23-10-2024)
  43. ChopraH. Annu, Shin DK, Munjal K, Priyanka, Dhama K, Emran TB. Revolutionizing clinical trials: The role of AI in accelerating medical breakthroughs.Int. J. Surg.20231091242114220
     [Google Scholar]
  44. ModiN.D. KichenadasseG. HoffmannT.C. HaseloffM. LoganJ.M. VeronikiA.A. SmitA.K. A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.BMC2023400
     [Google Scholar]
  45. ChauhanP. MendoncaM. Role of regulatory authorities on the working of contract research organization and pharmaceutical company’s clinical trials in India.Asia Pacific Journal of Health Management2021163879110.24083/apjhm.v16i3.961
     [Google Scholar]
  46. MirowskiP. Van HornR. The contract research organization and the commercialization of scientific research.Soc. Stud. Sci.200535450354810.1177/0306312705052103
     [Google Scholar]
  47. Van HuijsteeM. SchipperI. Putting contract research organisations on the radar: An exploratory study on outsourcing of clinical trials by pharmaceutical companies to contract research organisations in non-traditional trial regions.SSRN Elect. J.20112011175926510.2139/ssrn.1759265
     [Google Scholar]
  48. Study on CRO sector in India conducted by department of pharmaceuticals ministry of chemicals & fertilizers government of India.2023Available from:https://pharmaceuticals.gov.in/sites/default/files/CRO%20Market%20Report_High%20Resolution(accessed on 23-10-2024)
  49. DrabuS. GuptaA. BhadauriaA. Emerging trends in contract research industry in India.Contemp. Clin. Trials201031541942210.1016/j.cct.2010.06.008
     [Google Scholar]
  50. SariolaS. RavindranD. KumarA. JefferyR. Big pharmaceuticalsation: Clinical trials and contract research organizations in India.Soc. Sci. Med.2015131239e24610.1016/j.socscimed.2014.11.052
     [Google Scholar]
  51. Top 20 contract research organizations (CRO) - Asia-Pacific, especially India and China, positioned to benefit from rising financial and regulatory pressures in western pharmaceutical markets.2011Available from: https://www.prnewswire.com/news-releases/top-20-contract-research-organizations-cro---asia-pacific-especially-india-and-china-positioned-to-benefit-from-rising-financial-and-regulatory-pressures-in-western-pharmaceutical-markets-129287033.html(accessed on 23-10-2024)
  52. VanessaZ. Big ambitions for India’s contract research firms.C & EN20219929Available from:https://cen.acs.org/magazine/99/09929.html(accessed on 23-10-2024)
     [Google Scholar]
  53. A contract Research Organization.2024Available from:https://www.synteract.com/Services/Contract-Research-OrganizationAccessed(accessed on 23-10-2024)
  54. The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?Available from:https://www.maynardnexsen.com/publication-the-impact-of-covid-19-on-clinical-research-in-life-sciences(accessed on 23-10-2024)
  55. COVID-19 pandemic exemplifies the benefits of CROs.Available from:https://www.appliedclinicaltrialsonline.com/view/covid-19-pandemic-exemplifies-the-benefits-of-cros(accessed on 23-10-2024)
  56. VinothR. PandianP. KathiresanK. Contract research organisations in India- A review.Int. J. Biol. Pharm. Allied Sci.202211837693776
     [Google Scholar]
  57. NishiwakiS. AndoY. COVID-19 pandemic and treands in clinical trials: A multi-region and global perspective.Front. Med.20218111
     [Google Scholar]
  58. SathianB. AsimM. BanerjeeI. PizarroA.B. RoyB. Van TeijlingenE.R. NascimentoI.J.B. AlhamadH.K. Impact of COVID-19 on clinical trials and clinical research: A systematic review.Nepal J. Epidemiol.202010387888710.3126/nje.v10i3.31622
     [Google Scholar]
  59. TuttleK.R. Impact of the COVID-19 pandemic on clinical research.Nat. Rev. Nephrol.2020161056256410.1038/s41581‑020‑00336‑9
     [Google Scholar]
/content/journals/adctra/10.2174/0126673371332371241113103855
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Impact of Contract Research Organizations on Pharmaceutical Industries: A Review
Appl. Drug Resea., Clin. Trials and Regu. Affa. 11, E26673371332371 (2025); https://doi.org/10.2174/0126673371332371241113103855
/content/journals/adctra/10.2174/0126673371332371241113103855
/content/journals/adctra/10.2174/0126673371332371241113103855
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  • Article Type:     Review Article
Keyword(s): biotechnology industry; Clinical trial; contract research organizations market; COVID-19; pharmaceutical industry; sponsor

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