20 BioPharm International eBook February 2020 www.biopharminternational.com
Building Strategic Relationships
with CROs
How to adopt win-win strategies and understand quality agreements for
complying with cGMP.
P
harmaceutical and biopharmaceutical com-
panies have been extensively using con-
tract research organizations (CROs) to meet
their challenging needs in R&D and stan-
dard work for several decades. A noticeable
shift occurred in outsourcing research and clinical
work when Big Pharma R&D costs skyrocketed. For
example, in 2012, approximately 33% of drugs in the
pipelines of the top 10 pharmaceutical companies
were initially developed elsewhere (1).
Sponsor companies engage CROs either on a trans-
actional basis or on a strategic basis. In either case,
stakes are high for pharmaceutical and biophar-
maceutical companies to make sure CRO work is
successful. Neither selecting a reputable CRO, micro-
managing CRO work, nor throwing the work over
the fence leads to a successful CRO relationship.
Key strategies that can lead to a win-win relation-
ship include a relationship on a solid foundation
(CRO selection, quality management, and clarity
in expectations), soft factors (build the trust and
empowerment), and project management excellence
(simplifying the complex, metrics, and continuous
improvement). This article discusses these strategies
as well as FDA guidelines on quality agreements for
the contract manufacturing arrangements for drugs.
VADIMGUZHVA
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STOCK.ADOBE.COM
SHREEKANT KARMARKAR, PHD is president, DAT Pharma Consulting, Inc.,
skarmarkar@DATPharmaConsulting.com, Tel: 1.224.383.4493.
SHREEKANT KARMARKAR
Partnerships for Outsourcing Outsourcing
