In the ever-evolving landscape of clinical research, sponsors and CROs face numerous safety challenges across studies, from navigating complex country-specific and local regulations to managing multiple systems and technologies at clinical trial sites. The need for an efficient and streamlined solution becomes paramount to bridge gaps. Here, we explore how a centralized safety solution can harmonize site technology for clinical trial stakeholders, revolutionize precision safety report distribution, and the added benefit of unified training for clinical staff.
The Burden of Multiple Systems and Ever-Evolving Regulations
Clinical trial sites are often tasked with managing multiple systems and logins. The diversity of these systems across studies adds complexity to the workflow, leading to the over-distribution and underreporting of safety events. Moreover, in large clinical trials, sponsors must stay updated with hundreds of evolving country-specific rules. Distributing safety events (SUSARs, AEs, and SAEs) must align with each country’s unique requirements. Sponsors must identify any challenges and offer a solution that simplifies these complexities to achieve their study goals.
Evolving Regulations and Site Challenges
The clinical research landscape is in a state of constant flux. Ever-changing regulations and complex trials pose significant challenges for clinical sites. According to WCG’s 2023 Clinical Research Site Challenges Survey Report, 36% of sites reported trial complexities as a top issue. Also evident is technology’s growing prominence, with 18% emphasizing importance in 2023 compared to 10% in 2022. This shift can be attributed to staff training, increased time requirements for managing multiple systems and technologies, and the looming threat of cybersecurity in healthcare organizations.
The industry is recognizing and embracing technology as a solution to enhance efficiency in clinical trial safety.
Harmonizing Safety: The Key to Efficiency
InvestigatorSpace® addresses these challenges head-on, offering a comprehensive solution that combines safety notifications, training, and country-specific intelligence. With advanced features and GxP compliance, this holistic solution for clinical trial stakeholders includes:
- Unified System: Agile architecture enables clinical sites and study teams to use a single system and login credential for all their studies. This simplifies site operations and reduces administrative burden.
- Modern Application Integration: Flexible technology minimizes manual intervention and maximizes automation, making processes more efficient. It seamlessly integrates with Single Sign-On (SSO), CTMS, PV databases, and eTMF systems resulting in a comprehensive solution with built-in error management.
- SMART Country Distribution Rules: Ensure compliance, deliver higher efficiency, and reduce overdistribution with InvestigatorSpace’s intelligent technology that automates the distribution of safety events based on country-specific and local regulations.
- Out-of-the-Box Country Configurations: Ensure seamless compliance with 125+ country regulations with best-in-class country-specific configurations.
- Safety Reference Model: Continuously harmonized rules based on insight from over 50+ sponsors and CROs in the industry. This model ensures best practice safety distribution and reporting.
- Unified Training: Investigators must provide proof of their qualifications to perform safety-related activities. Sponsors can streamline their processes by housing all training topics for sites working on their studies in InvestigatorSpace.
- End-to-End Service Delivery: InvestigatorSpace operates as a Software as a Service (SaaS), providing a complete, up-to-date solution for clinical trial stakeholders.
Technology as a Solution: Active in 1,000+ Studies
InvestigatorSpace is the industry’s most widely used safety solution, with over 300,000 users benefiting from its features. As clinical research evolves with complexities and constant change, InvestigatorSpace offers a powerful solution for harmonized safety distribution, reporting, and training. By streamlining technology at sites and automating the adherence to country-specific regulations, InvestigatorSpace makes the entire process more efficient and manageable. Additionally, it allows sponsors, CROs, and clinical sites to focus on what truly matters – advancing medical science and improving patient lives.
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