|Articles|September 1, 2009

Applied Clinical Trials-09-01-2009
Volume 0
Issue 0

Applied Clinical Trials Digital Edition - September 2009

REGULATORY : Comprehensive Guide for Generic Drug Trials The Unique Concerns of Recombinant DNA Research TRIAL DESIGN : A Crash Course in Adaptive Also in this issue : Sponsors Challenged by Globalization, GCP Inspections Unite EMEA and FDA, Post Credit Crunch R&D Opportunities

External Link - article-821306.pdf

Articles in this issue

about 17 years ago

Article

The Spotlight Falls on India

about 17 years ago

Article

eClinical Software: September 2009

about 17 years ago

Article

Into the Aftermath of M&A

about 17 years ago

Article

EMEA and FDA Team Up on GCP

about 17 years ago

Article

Does Size Matter in Partnerships

about 17 years ago

Article

An Assessment of Adaptive

about 17 years ago

Article

Business and People Update September 2009

about 17 years ago

Article

eCTD Training Efforts

about 17 years ago

Article

Global Development Challenges Sponsors

about 17 years ago

Article

Regulating the Generic Drug Process

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.