Partnering & Outsourcing Editorial

  1. Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning 8/17/2023

    FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.

  2. Full-Service Or Specialty CRO: Which One Is Right For You? 7/24/2023

    The pool of capable CRO organizations from which to choose is vast, so when it comes time to select whom you should outsource, there is no one-size-fits-all answer or "best" option. Ask yourself these five questions when considering whether to hire a full-service CRO, specialty CRO, or a combination of both.

  3. Save Time And Money By Using AI To Compare CRO Proposals 7/21/2023

    Old way versus new way. Audrey Rossow, director of clinical operations at Precirix, examines tried and true methods of finding outsource partners with the up-and-coming AI technologies that aim to make that process quicker, easier, and possibly cheaper.

  4. Key Questions To Ask When Entering A Pharma Partnership 6/7/2023

    Before entering a partnership, pharma and biotech executives need to ask themselves and their prospective partners key questions in five important areas.

  5. Remote Candidate Fraud In Clinical Research: A Cautionary Tale For Interviewers 5/23/2023

    You interviewed a remote candidate for a technical role who nailed it. The interview panel unanimously agreed to move forward, and the candidate skated through the new hire screening. You set them up on a project that fits their skillset perfectly, and you were excited for their first day. But when the candidate started, things seemed… off.

  6. India's CROs & CDMOs Come Of Age In The Global Marketplace 5/4/2023

    Most of the top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.

  7. Key Considerations For Working With CROs 4/25/2023

    Learn the key considerations for selecting a clinical research organization (CRO) outsourcing partner for your clinical trial as well as how to mitigate the four common challenges while working with CROs.

  8. Why Every Pharma Needs A Service Management Group (SMG) For Successful Outsourcing 4/24/2023

    A comprehensive end-to-end sourcing and outsourcing approach can allow life science companies to realize their clinical transformation objectives. One of the critical areas not getting enough attention is the design and development of an internal, dedicated Service Management Group (SMG) that is adequately staffed, trained, and empowered to manage the multiple suppliers and the strategic objectives of the outsourcing programs.

  9. Need To Clean Up Your Clinical Trials Budgeting And Forecasting Process? Try MOP-FACE 4/17/2023

    Like the CTM who drinks CDER at the SPA without getting anyone SAD or MAD, our industry enjoys a good acronym. As such, here is the acronym to remember that will lead you to budgeting enlightenment: MOP-FACE.

  10. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.