BioPharm International - May 2022

BioPharm International- May 2022

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www.biopharminternational.com May 2022 eBook BioPharm International 13 years will be problem-free. Business relationships are no different. When issues surface, it is important to be able to resolve them quickly and get on with the study because time is money in research. If there is gross negligence on the part of the CRO, the solution might be to part ways, as prolonging the relationship might ultimately cost millions of dollars. If a CRO puts a lot of effort into a project but still fails, a sponsor and CRO might be in a learning situation to see whether both sides can figure out what could have been done to prevent the problem and what steps need to be done to pr e v ent t he is sue f rom reocc u r r i ng. U lt i mately t he be st relationships, no matter what the model, are built on trust, open communication, and the ability to challenge each other. Setting high expectations complement the relationship because it implies a le v el of t r u st a nd i mprov e s t he probability of success. REFERENCES 1. H. Balfour, "Biotech and Pharma Services Outsourcing Market to Be Worth over $91bn by 2028," EuropeanPharmaceuticalReview. com, April 13, 2021. 2. Imarc Group, Preclinical CRO Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021- 2026, November 2021. 3. Rocci M et al., Outsourcing Best Practices, American Association of Pharmaceutical Scientists, April 28, 2021. 4. FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (CDER, CBER, Dec. 2012). 5. A. MacGarvey, "Functional Service Provision vs. Full- Service Outsourcing," ContractPharma.com, June 4, 2020. 6. CFR Title 21, Chapter 1, Subchapter A, Part 58 (Government Printing Office, Washington, DC). 7. CFR Title 21, Chapter 1, Subchapter C, Part 2010 (Government Printing Office, Washington, DC). 8. F. Mirasol, "Biopharma Industry is Seeing Merit in Early Preclinical Strategies," BioPharm International 34 (11) 36–37 (2021). 9. D. Talerico, "A Guide to Remote Audits of Research Studies," criver.com/eureka, Sept. 2, 2020. 10. L. Henderson, "The State of CRO and Sponsor Relationships," Applied Clinical Trials 22 (10) 26–29 (2013). 11. R. Mullin, "COVID-19 is Reshaping the Pharmaceutical Supply Chain," cen.acs.org, 8 (16) (2020). BP Partnerships for Outsourcing Development CALL FOR PAPERS BioPharm International accepts four types of peer-review papers that are considered: standard data-driven, novel research; topical literature or patent review; technical case studies/technical application notes; and science-based opinion papers. Manuscripts for peer-review papers are accepted on an ongoing basis. Publication priority is given to papers in the order they are accepted for publication. Submitted papers are initially screened by the editors, then submitted for formal review by a member of the editorial advisory board, who will review the article for technical interest and content in a double-blind review process. Article acceptance is conditioned on the reviewer's approval. Once accepted for publication, a paper typically is published within three to five months. Peer-review papers are published in the print and digital editions of BioPharm International, and on www.BioPharmInternational.com. Links to the online versions of peer-review papers also are featured in e-newsletters distributed to the publication's audience. To learn more about the peer-review submission process, click the Submission Guidelines link on www.BioPharmInternational.com. C A L L FOR PAP ERS C A L L F O R P A P E R S CALL FOR PAPERS

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