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International Clinical Trials
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Over the past few years, outsourcing clinical trials has become an
attractive option for sponsored pharmaceutical research. Therapeutic
expertise, resource management, technological advantages and cost
cutting are some of the primary reasons for any biopharmaceutical
sponsor to outsource clinical trials. This has led to tremendous growth
in the size and number of CROs in the past two decades. Most of them
position themselves as a fullservice CRO in the drug development market,
although – based on study-specific requirements – the majority of them
are ready to sub-source for their functional needs.
Collaborating
with a CRO is now an essential and significant step for sponsors during
the clinical development process. The dynamic shift in outsourcing
methodology and service fragmentation has left them with critical
decisions to be taken at the juncture of CRO sourcing. There are
variable sizes of companies on both the sponsor and the CRO side, and
the principle of ‘one size fits all’ is not pragmatic from an
operability perspective.
Different Options
Full-service
and functional outsourcing remain as two distinct but basic models of
collaboration. Traditionally, per-study outsourcing has been followed
until recently, when strategic partnerships between Big Pharma and
sizeable CROs began gaining popularity.
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Business Continuity Plan - Message from Protagen Protein Services (PPS)
Following the recent COVID-19 outbreak, we at Protagen Protein Services (PPS) are preparing for all eventualities. Please be assured that PPS will continue to operate as normal providing you with all of the professional support and service you have to come to expect from us.
Given the gravity of the situation, and to protect our staff, clients, and communities from the spread of the virus, we have taken various measures within a scope of a Business Continuity Plan:
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The Role of the CRO in Effective Risk-Based Monitoring
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The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
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Formulation and Drug Delivery Series UK
8-9 July 2020, Oxford Global
This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
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