Global CRO Body Addresses Data Integrity In Decentralized Trials

The Association of Contract Research Organizations’ revised toolkit on decentralized trials explains how to deal with data quality and integrity. 

Data synchronization of health book between smartwatch and smartphone in male hands
COVID-19 Has Highlighted The Need For Clinical Trials To Allow Remote Participation • Source: Shutterstock

The international Association of Contract Research Organizations has updated its toolkit on best practices in decentralized clinical trials with new “data flow maps” to address issues around data integrity and data quality.

The toolkit was first issued last September and, according to ACRO, has been a valuable resource during the COVID-19 pandemic....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from International

Global Pharma Guidance Tracker - May 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

More from Geography

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By 

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.