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5 Steps To Mastering Global Clinical Trial Disclosure Compliance

 
• By Thomas Wicks

Clinical trial disclosure compliance must include identification and documentation of registry requirements, key stakeholders, company policies, systems, and processes.

gears steps to manage clinical trial data transparency
Sponsors can implement a straightforward five-step process to take control of trial transparency. • Source: Shutterstock

Many biopharma companies remain challenged to comply with mandatory government requirements for disclosing clinical trial information, whether due to lack of knowledge or lack of effective corporate policies and procedures. A strategy including documenting disclosure requirements and trials subject to disclosure, identifying internal stakeholders with compliance responsibilities, implementing policies explicitly endorsed by top management, and tapping into useful tech tools can help remedy the problem.

The stakes can be significant. With increasing scrutiny by transparency advocates and the start of inspections by health authorities, the...

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More from Clinical Trials

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 
• By Neena Brizmohun

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

More from R&D

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.