Whitepaper

Atlas Global Compliance: Tracking and Managing Global Disclosure Performance

The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.

Whitepaper

Trial Results Summary: Improving Patient‐Centric Communications

This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of technology to more quickly, efficiently and reliably provide trial results summaries to trial participants.

Whitepaper

Clinical Trial Transparency: The Technology Imperative

Clinical trial sponsors are taking varying approaches to transparency, driven in large part by new clinical trial registration and reporting regulations. The combined effects of increasing complexity, shorter deadlines, and continued calls for greater transparency demand a technology approach to clinical trial disclosure. 

Whitepaper

Clinical Trial Reporting Compliance: Self-Assessment Survey Results from Pharma, Biotech, and Academic Trial Sponsors

This report allows the trial sponsors to ‘grade’ themselves on actual and perceived compliance compared to their peers, which may be helpful in adjusting their organization’s trial disclosure policies, responding to questions raised in journal articles, and better understanding the public perception of their disclosure activity.

Whitepaper

Introduction to Clinical Trial Disclosure

Clinical Trial Disclosure is a compliance requirement that faces life sciences organizations around the world. The complexity of working with evolving health authority requirements and managing dynamic clinical trial data on a global basis can be significant. It is important to understand the context of disclosure in order to appreciate the rationale for registering clinical trials and reporting trial results. This paper offers a brief history of regulations, an overview of requirements and a discussion of the consequences of noncompliance.

Whitepaper

Risk-based Validation of SaaS Solutions

System validation refers to a company’s approach to ensuring that a system (a combination of hardware, software, users, training and processes) meets its intended use and provides a consistent, predictable output. Documentation throughout the Software Development Life Cycle (SDLC) is required from software vendors to illustrate that procedures are followed and controls are implemented to produce quality software. It is the life sciences organization’s (sponsor) responsibility to develop a validation program for a system in the context of their operating procedures.

Case Study

Improving Compliance While Reducing Resources

Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov). The Company had approximately 200 clinical trials that required registration and ongoing disclosure maintenance. The team needed an additional 20 hours per study to update, finalize, approve and release one update to a study registration. Once results were available, 80 hours of resource time was required to draft, finalize, quality check, approve and release one initial study’s results.

Case Study

One Source Drives One Process for Clinical Trial Transparency

Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

A global top 10 clinical trial sponsor was challenged by lengthy, resource intensive processes to support compliance in clinical trial registration and results reporting. The Company wanted to improve these processes and reduce the time and cost of maintaining compliance. The sponsor team was also having difficulty managing dynamic clinical trial data that was being pushed to registries and simultaneously to the sponsor’s own public website. Inconsistencies between the sponsor site and registries required double data entry and redundant quality control processes requiring additional resources, time and costs and increased the potential for errors.

Case Study

Synching Transparency Processes to Improve Compliance

The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.

A global sponsor was employing a combination of emails, spreadsheets and manual processes to manage their clinical trial disclosure activities. Redundant data entry and maintenance activities across disjointed tools were running in parallel in order to populate multiple global registries. In addition, the sponsor’s homegrown system for managing content for their own branded clinical trial transparency site was difficult to use and expensive to maintain. The tools and processes were not scalable and were wasting valuable resources on labor-intensive, manual processes that were put in place to guard against data entry and version control errors.

Presentation

Why Trial Sponsors Fail to Comply with Global Transparency Requirements.

Watch Why Trial Sponsors Fail to Comply with Global Transparency Requirements on demand.

Webinar attendees will understand the main reasons why trial sponsors may fail to comply with global disclosure regulations or the expectations of transparency advocates, learn how leading sponsors are taking control of their transparency obligations, and see examples of tools that will help you ensure consistent compliance with disclosure regulations and policies

Presentation

Webinar: The Global Disclosure Challenge: What You Need to Know

In this webinar, TrialScope’s Disclosure Experts discuss how the scope of global disclosure activities has expanded to include evolving requirements for local health authorities, transparency advocates and company policies. This webinar delves into the global compliance challenge as well as the numerous risks that should be considered. It will also share the benefits of good disclosure performance and demonstrate TrialScope’s new Atlas Global Compliance solution.

Presentation

Webinar: An Innovative Approach to Trial Results Summaries

The presenters in this webinar will discuss how they are employing technology to replace outdated, paper-based patient communications about trial results. This innovative approach enables clinical trial sponsors to meet their ethical obligations to trial participants while simultaneously increasing patient engagement, thus providing benefits to sponsors and their trial participants.

 

Presentation

Webinar: Clinical Trial Disclosure: Predictions 2017

TrialScope’s clinical trial disclosure, compliance and transparency experts share their expectations of the challenges and changes we can expect in 2017. The presenters also provide recommendations and best practices to help clinical trial sponsors navigate the increasing complexities of clinical trial transparency.

 

Presentation

Webinar: Clinical Trial Disclosure: The Technology Imperative

Clinical Trial Disclosure: The Technology Imperative

Join TrialScope’s experts as we discuss how the role of technology in the clinical trial disclosure process will continue to grow.

The presentation will include:

  • Key factors shaping clinical trial disclosure today
  • Opportunities where technology can add greater efficiency and compliance to your disclosure processes
  • Areas of concern for teams that continue to use manual processes

Presentation

Webinar: Five Reasons You May Look Non-Compliant (and What You Can Do About It!)

Join Thomas Wicks, Chief Strategy Officer, TrialScope as he shares the top five reasons why sponsors may appear non-compliant and what you can do to fix the problems. He articulates the differences between apparent and actual transparency and the reason that publicly available disclosure data may not be telling the whole story.

Presentation

Webinar: Maintaining a Validated SaaS Solution

Part 2 of a 2 part Series 

In this webinar the TrialScope team shares best practices and upgrade strategies for maintaining a validated SaaS solution. Validation activities including planning, testing and training will be discussed along with key deliverables,  and the roles and responsibilities of vendors and sponsor teams.

Presentation

Webinar: Implementing a Validated SaaS Solution

Part 1 of a 2 part Series

SaaS solutions are increasing in popularity across the life sciences industry. Yet clinical trial sponsors continue to struggle to develop and execute their approach to validation as they implement SaaS solutions. In this first webinar in a two part series, the TrialScope team shares best practices for implementing a SaaS solution. Highlights include guidance on developing a risk-based approach, questions to ask your technology vendor and recommendations regarding who should be on your validation team.

Presentation

Webinar: Clinical Trial Disclosure Maturity Assessment 2016: What You Need to Know

Industry-leading clinical trial sponsors are continuing to invest in their people, processes and technologies to develop consistent and sustainable clinical trial disclosure capabilities. TrialScope has developed a maturity assessment tool to gain a cross-sponsor benchmark of established approaches and best practices that these capabilities are built upon. Presenters in this webinar will discuss the 2016 results of the TrialScope Clinical Trial Maturity Assessment and share trends, evolving requirements and challenges that impact clinical trial disclosure processes.

Presentation

Are You Ready for the Changes Coming with NPRM and the EU Portal?

The NPRM in the US and the European Clinical Trial Regulation in the EU promise to put additional time pressures on clinical trial disclosure teams. Is your team ready to meet these emerging requirements?These evolving requirements are moving clinical trial sponsors to improve responsiveness, address data governance issues and review data sources and processes, all while maintaining data integrity and compliance. View the webinar to see Thomas Wicks, Chief Strategy Officer and Matt DeFranco, Senior Product Specialist, identify practical approaches for disclosure teams to start preparing now for NPRM and the EU Clinical Trial Regulation.

Presentation

Clinical Trial Results Disclosure – Clinicaltrials.gov to EudraCT Mapping

The following presentation provides an analysis of field and content mapping between clinicaltrials.gov and EudraCT.

Infographic

Clinical Trial Disclosure

Clinical Trial Disclosure is a global topic. Check out our infographic to learn interesting facts about disclosure, global registries and TrialScope’s products.

Tools

Ten Big Questions to Ask Your Clinical Transparency Solutions Provider

Clinical trial disclosure is a complex and dynamic process. When you are considering a clinical trial disclosure solution, it is important to know what questions to ask the vendor/partner. The experts at TrialScope have compiled the ten most important questions you should be asking. They cover a broad range of topics from practical experience to quality management programs. Incorporate these into your evaluation process to ensure that you select the right solution for your disclosure needs.