May 17, 2017 – Clinical trials are inherently high risk and any errors can result in major disruptions or completely collapse the trail. It is extremely telling that only 12% of medicines in clinical trials make it to patients and, whilst there are many reasons that a trail could be unsuccessful, there is potential to mitigate some areas of risk and error.
May 17, 2017 – Regulatory affairs as an internal-company function encompasses a range of areas, but largely concerns the maintenance of already-approved drugs. Because filings vary slightly internationally and need to be harmonized at a global level to remain compliant, just keeping a license to sell, keeping it consistent and maintaining transparency is a huge task.
April 13, 2017 – ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO. According to the clinical trial transparency and compliance solutions provider, ATLAS Global Compliance enables sponsors to ensure trials are compliant by consolidating information from all trial sites into one view.
April 10, 2017 – The pharmaceutical industry is witnessing a deep shift in the traditional approach to patient disclosure in clinical trials. While most companies are struggling to meet basic compliance requirements, a longer-term objective has emerged that is shifting the transparency goal post.
March 22, 2017 – In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.
March 13, 2017 – AstraZeneca partnered with TrialScope to launch the Trial Results Summaries Portal, a website that allows sponsors to pay to input their trial results, and trial participants can check to see what became of the trial in which they participated.
March 10, 2017 – In the world of clinical trials, many life science companies will love you and leave you. They take the data and the clinical notes, with no effective feedback loop or post-study engagement.
January 19, 2017 – In 2007, the Food and Drug Administration Amendments Act (FDAAA) was passed. Title VIII of this act requires sponsors to register and provide results for Applicable Clinical Trials (ACTs) on a public database.
January 5, 2017 – 2017 will be a challenging year marked by public scrutiny of disclosure practices by regulators, stakeholders, and watchdog organizations. Expanded regulations require a significantly broader range of data to be disclosed within ever tighter timelines.
April 7, 2016 – The technology advancements in the pharmaceutical and life sciences industry is driving a paradigm shift across the business—from powerful new drug chemistries to innovative R&D partnerships and marketing plans.
January 6, 2016 – I recently had the opportunity to host TrialScope’s Leadership Forum on Clinical Trial Transparency. The attendees, representing organizations that conduct global clinical trials, had come together to discuss pending changes to global transparency requirements, which will increase the scope of disclosure and shorten timelines.
August 31, 2015
Thomas Wicks, TrialScope’s Chief Strategy Officer, participates in a video interview with Taren Grom from PharmaVOICE at the DIA Annual Meeting in Washington, D.C. Thomas shares his thoughts on his leadership role within TrialScope and within the industry.
August 25, 2015
There are over 40 countries or regions with mandatory trial disclosure regulations and over 30 trial registries for posting clinical data. Few sponsors have evolved systems for continuous monitoring of trial disclosure and registry requirements. Thomas Wicks describes four practices that rise to the surface as major risks for trial sponsors regarding current and ongoing compliance.
June 1, 2015 – Clinical Trial Disclosure is a complex compliance challenge that clinical trial sponsors around the world face every day. The complexity of managing dynamic clinical trial data and working with evolving health authority requirements on a global basis can be significant, and the sheer quantity of trials being conducted today only increases the complexity of this task.