Timothy Roe | CEO
Arriello

Day 2: 15th October @ 11:05

Managing the Complexity of Scale: Why Specialised Safety Providers Outmanoeuvre Large CROs

The clinical development landscape is complex, particularly for rare diseases and specialized therapeutics. Selecting a Pharmacovigilance (PV) partner is a decision that affects not only daily operations but also the ultimate viability of a New Drug Application (NDA) or Biologics License Application (BLA).

Large, integrated CROs hold a healthy position where they excel. This primarily lies with post-marketing, high-volume case-processing transactions and established sponsors with extensive, multi-product portfolios. This is their “sweet spot.” They also have a large pool of professionals to draw from, often siloed within the organization.

This presentation examines the systemic failures often observed when SEBOs partner with a large, integrated CRO for high-stakes clinical trials, particularly in managing their PV system.

Despite SEBOs’ intensive and often frustrating remediation efforts, the rigid, transactional model characteristic of the industry's largest CROs frequently introduces critical risks to study integrity, data quality, and resource management.  For specialized clinical programs, transitioning to a nimble, expert-driven PV service provider is not merely a preference, but is quickly becoming a regulatory and financial necessity.

Timothy Roe, CEO, Arriello

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Timothy Roe / Managing the Complexity of Scale: Why Specialised Safety Providers Outmanoeuvre Large CROs

Timothy Roe, CEO,
Arriello

Timothy Roe leads M2D Global Life Sciences, a specialized consulting and advisory firm serving biopharmaceutical organizations across all stages of clinical development. With deep expertise in pharmacovigilance governance, regulatory strategy, and outsourcing models, Timothy advises senior...

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