Outsourcing Pharma

  1. Choosing A Development-Stage eCOA/ePRO Provider 8/2/2018

    ISR asked study sponsors, CROs, and clinical research sites what’s the most important attribute they would use to select an eCOA (electronic clinical outcomes assessment)/ePRO (electronic patient reported outcomes) provider for development-stage products.

  2. What Makes It So Hard To Select A CMO? 7/5/2018

    An unexpected finding from ISR’s research with regards to contract manufacturing from the perspective of a market researcher. The data come from Industry Standard Research’s CDMO Outsourcing Models survey.

  3. What Are The Largest Slices Of The 2018 CRO Market? 7/5/2018

    2017 was another strong year for CRO growth, with all major/public service providers experiencing year-over-year revenue gains. The largest component of CRO market revenue by geography, development, and service line is highlighted here.

  4. Brand Strength And The Contract Manufacturing Competitive Landscape 5/2/2018

    Results of a survey asking interviewees about their preferred category of CMO for a certain type of outsourced manufacturing work — full-service CDMOs with end-to-end capabilities or specialty contract manufacturers with expertise in particular areas of need.

  5. Batter Up: The Starting 9 GDPR Takeaways For CROs 4/6/2018

    While many of the core data protection responsibilities outlined in the GDPR are not new to organizations involved in research, the GDPR nonetheless will have significant repercussions for CROs. With the baseball season coming up and the GDPR effective date around the corner, here are the “starting nine” GDPR takeaways for CROs.

  6. Outsourcing Preformulation: An Intersection Between Technology And New Business 3/7/2018

    Today, pharma companies of all sizes have limited patience for delays in development and need to rapidly determine the relative risks of formulation decisions.

  7. Quality Adds Empathy To Outsourcing 3/7/2018

    Vinita Kumar, VP of quality at Versartis, talks about how her philosophy on CMO collaboration has been field-tested. “Never does that importance of real collaboration reveal itself more than in hard times for your program when you need it most,” she says.

  8. Losing Sight Of The Intended Purpose Of Specifications Has Consequences For The CMO-Sponsor Relationship 3/7/2018

    Current practices for specification-setting in the pharmaceutical industry have drifted from the intended purpose of specifications. There is growing recognition of this disconnect, resulting in a number of industry teams, regulatory initiatives, and conference sessions on the topic.

  9. Lucky Seven For Winning CDMOs — And Their Sponsors 3/7/2018

    Outsourced Pharma Chief Editor Louis Garguilo talks about what makes this seventh edition of the Life Science Leader CMO Leadership Awards different from the previous years.

  10. Outsourcing Relationships Benefit From Aligning CMO Expertise With Sponsor Needs 3/7/2018

    This year’s CMO Leadership Awards result from feedback obtained through four different contract manufacturing surveys — biologic API, biologic drug product, small molecule API, and small molecule drug product — conducted by Industry Standard Research.