Partnering & Outsourcing Editorial

  1. 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.

  2. 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.

  3. 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.

  4. The Secret(s) To Solving The Clinical Trials Staffing Crisis 2/10/2023

    In September 2022, there were 6.6 million clinical research jobs posted in the U.S. but only 5.7 million available hires. What accounts for the hiring gap, and how can it be narrowed? Kathi Enderes, SVP, research, and global industry analyst, at The Josh Bersin Company explains why looking outside the field is one way to address worker shortages.

  5. 4 Essential Drivers In Clinical Development For Emerging Biotechs 12/21/2022

    Enrollment, enrollment, enrollment has been the sponsor’s classic mantra for achieving success in a clinical trial. Rather, we should replace this notion with four equally essential building blocks: 1) the selection of the right CRO, 2) the identification of study sites, 3) the engagement of sites, and 4) the enrollment of patients.

  6. The Future Of TransCelerate: Clinical Trial Modernization 12/19/2022

    In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.

  7. Boehringer Ingelheim Implements One Medicine Technology Platform 12/8/2022

    For years, Boehringer Ingelheim operated with a system comprised of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.

  8. How CVS, Walgreens, And Walmart Will Improve Clinical Trial Recruitment 11/30/2022

    A new development could potentially change the patient recruitment challenge. In 2022, CVS, Walgreens, and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the patient diversity problem.

  9. Portage Biotech Creates A New Drug Development Model 11/21/2022

    While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.

  10. A 3-Point Strategy For Training Part-Time GCP Consultants 11/17/2022

    Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.