Sciteline Virtual Clinical Trials (VCT) 21 CFR Part 11 Compliance White Paper

Research organizations are increasingly benefitting from the advantages of decentralized solutions. These companies must adhere to the regulatory requirements of United States (U.S.) Federal Regulation Title 21, Chapter 1, Part 11 (21 CFR Part 11) if using electronic records and electronic signatures in place of paper-based records to comply with FDA rules.

Many organizations are choosing Sciteline’s Virtual Clinical Trial (VCT) product to digitize patient informed consent, patient reported outcomes and clinical assessment outcome processes. 21 CFR Part 11 requirements can be satisfied using VCT when it’s properly configured to execute electronic signatures.

This paper presents an assessment of the technical features and the procedural controls that allow for the application of 21 CFR Part 11 compliant signatures using Sciteline’s VCT product. The assessment focuses on how Sciteline’s Virtual Clinical Trial (VCT) product and the research organization using VCT share responsibilities for achieving compliance.

Decentralized trials: A new patient-researcher compact

Why do patients drop out of clinical trials? The answer is multilayered, but many point to the burden that a clinical trial places on the patient’s everyday lives. Our new white paper explores these challenges and how decentralized trials can make a meaningful impact on reducing patient burden.

The sections of this paper includes the following:

  • Overview of patient burden in clinical trials
  • Decentralized trials as a new alternative to traditional methods
  • How Sciteline can help through the following product features:
    • Screening and eConsent
    • Monitoring via Electronic Patient Reported Outcomes (ePROs)
    • Telehealth and Virtual Visits
    • Safety Alerts
    • Study Dashboards

Optimizing patient recruitment in clinical trials

More than 80% of clinical trials fail to meet their patient recruitment timelines. Improving the patient recruitment process is key to avoid costly delays in bringing new treatments to market.

Our latest whitepaper explores strategies to improve the patient recruitment process, including data driven protocol design, breaking down knowledge-access barriers to patients, engaging community leaders and embracing continuous patient engagement.

Learn what Sciteline is doing to innovate the patient recruitment process to allow research teams to accelerate clinical trial recruitment timelines and build deeper relationships with patients.

DIA 2021 Reflections

At the height of the COVID-19 pandemic, thousands of clinical trials were either suspended or stopped all together due to safety concerns or regional lockdown conditions.

The DIA 2021 virtual global annual meeting in June brought together many key opinion leaders, researchers, and partners across the industry to discuss how they leveraged novel processes and technologies to continue their work during this challenging time.

How did the industry come together to leverage new processes and innovative technologies to overcome the challenges posed by the pandemic? What new opportunities were discovered that can address long standing challenges in clinical research? What’s next as we move forward and apply our key learnings from the pandemic?

Our latest blog shares perspectives on DIA 2021 and our key takeaways from the meeting.

The Future of Patient Registries

Patient (or disease) registries can play a crucial role in providing a real-world picture of a disease or medical condition.

Patients and researchers have long been using registries to help build communities and to drive the need for more research within a particular disease area or patient population.

The availability of real-world data in registries has the potential to improve quality of life, update treatment guidelines and enhance patient safety.

So why are they not being adopted widely? What are the current challenges researchers face with developing and maintaining effective patient registries? How can technology play a role to improve the quality of patient registries today?

Our latest blog explores these questions and how researchers can make patient registries an integral part of advancing standard of care.