|Articles|January 25, 2018

A Clinical Research Reality: Standardization of R&D Outsourcing

It has been announced that steps have been taken in the standardization of R&D outsourcing. IAOCR and the Pharmaceutical Contract Management Group have taken steps to include a core competency framework for outsourcing managers and a training course, Outsourcing Essentials to develop these standards. Both organizations came together in common ground wanting to improve standards of best practice in the clinical research sector.

Read the full release here.

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

September 30th, 2026

Where AI Leads in Trial Design—and Where Humans Still Need To

In this video interview, Claire Riches, VP of clinical solutions at Citeline, makes the case for AI as a sophisticated strategic advisor in trial design while arguing that humans must remain in the lead—especially when factors the model can't fully account for are at stake.

September 30th, 2026

ACT Brief: Enrollment Feasibility Pressure-Testing, RWE Infrastructure Gaps, and Peptide Rulemaking Standstill

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.

© FlowStudio - © FlowStudio - stock.adobe.com

September 29th, 2026

Real-World Evidence Is Moving Upstream: Is the Data Infrastructure Ready?

RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.

September 29th, 2026

The Data Inputs That Matter Most When Pressure-Testing a Protocol's Feasibility

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance data with real-world patient data and site-level recruitment history gives sponsors a far more honest picture of whether their enrollment assumptions are actually achievable.

September 29th, 2026

ACT Brief: Trial Simulations and Protocol Risk, RBQM Financial Value Quantified, and Three Drug Approvals

In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.

September 28th, 2026

Quantifying the Financial Value of RBQM: Q&A with Sylviane de Viron, CluePoints, and Abigail Dirks, Tufts CSDD

In this Q&A, Sylviane de Viron of CluePoints and Abigail Dirks, MS, of Tufts CSDD discuss the findings of a collaborative study quantifying the financial value of RBQM, why time savings emerged as the largest driver, and what sponsors struggling to justify adoption now have that they didn't before.

September 28th, 2026

The Design Flaws Trial Simulations Surface That Traditional Planning Misses

In this video interview, Claire Riches, VP of clinical solutions at Citeline, walks through the categories of hidden protocol risk that AI-driven simulations can identify—from overly restrictive eligibility criteria to patient dropout patterns and structural trial assumptions.

September 28th, 2026

ACT Brief: AI Expands Endpoint Options, CRO Oversight Documentation, and Kidney Cancer Approval

In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.