Clinical trial disclosure compliance is challenging, whether a sponsor is registering five trials or 500 trials.
NEW YORK, March 30, 2023 (GLOBE NEWSWIRE) -- Clinical trial disclosure compliance is challenging, whether a sponsor is registering five trials or 500 trials. Compounding the complexity is the fact that no global standards exist for disclosure. With ever-changing global regulations, new requirements on the rise and the threat of monetary penalties, study sponsors are feeling the pressure to maintain compliance, minimize risk and safeguard their brand reputation.
Created for by disclosure experts for any professional overseeing the disclosure process in life sciences organizations — disclosure, regulatory affairs, ClinOps and others — Citeline’s new TrialScope Intelligence platform is an all-in-one disclosure solution that centralizes the critical knowledge needed in clinical research for timely compliance with global clinical trial requirements. Citeline’s portfolio of solutions and services covers all aspects of drug development: clinical, regulatory and commercial. TrialScope Intelligence complements Citeline’s flagship regulatory solution, TrialScope Disclose, the industry’s most widely used platform for clinical trial disclosure management.
TrialScope Intelligence empowers compliance stakeholders to proactively plan trial disclosure throughout the clinical lifecycle. In an easily digestible format, it provides granular, country-specific requirements for close to 200 countries, English translations, disclosure trends and insights, all with intelligent, action-oriented functionalities.
With TrialScope Intelligence, users regain hours previously spent searching, mining data for pertinent regulatory information, keeping up to date and monitoring trends. TrialScope Intelligence also enhances collaboration across teams and favors alignment with external parties.
Just as parent company Norstella helps life sciences clients navigate each step of the drug development life cycle, Citeline’s TrialScope Intelligence helps study sponsors navigate the complexities of clinical trial regulations.
“Our mission,” said David Laky, Citeline’s Clinical and Regulatory General Manager, “is to help sponsors understand their regulatory requirements in advance of starting a clinical trial and reduce the risks of noncompliance by helping them sharpen their knowledge, strategize, plan out and manage timely clinical trial disclosures globally. With TrialScope Intelligence, sponsors know what, when, why and how they need to comply.” He explained that each branch of the solution is validated along the way, with new branches to be added, as TrialScope Intelligence continually evolves post-launch. “It’s an iterative cycle, and it’s meant to never end.”
Clinical trial disclosure, in addition to meeting legal requirements, reflects sponsors’ commitment to transparency. This translates to increased investor confidence, public trust, and patient participation in clinical trials.
Learn more about TrialScope Intelligence.
About Citeline
Citeline, a Norstella company, powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial, and regulatory-related decisions and create real-world opportunities for growth.
Citeline’s global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts and more. For more information on one of the world’s most trusted health science partners, visit Citeline.
Citeline PR contact:
Diffusion PR for Citeline
citeline@diffusionpr.com
(213) 318-4500
