Outsourcing Pharma
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A Combination Of Reliability, Quality, Capabilities, And Expertise Add Up To Outsourcing Success
3/1/2019
Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and the corresponding market research data, can be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.
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BeiGene Exec Talks Candidly About Quality, Compliance, And Outsourcing
2/1/2019
Outsourced Pharma Chief Editor Louis Garguilo continues his coverage of the current state of China pharma manufacturing by interviewing Diana Francis, VP of quality and compliance for BeiGene.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.