Trial optimization makes all the difference in today’s complex clinical landscape, aiming to make your trials more efficient, compliant, safe, and driven by effective recruitment strategies.
We’ve created a cross-functional team that works together to form a cohesive trial optimization network. As a result, you get an entire “ecosystem” of accessible experts who provide complete transparency and support around patient recruitment, feasibility, site identification and partnerships, RBQM, diversity, rater training, and more. Trial optimization ensures your money and time are spent as efficiently as possible, maintaining trial quality and prioritizing patients’ needs above everything.
Patient recruitment and retention pose significant challenges in achieving timely study milestones due to financial and geographical constraints, while sites often struggle with resource limitations and incomplete protocol understanding.
Our solutions focus on understanding the everyday realities of sites and patients, providing site support to alleviate barriers and addressing patient perspectives. By prioritizing study success with proactive scenario planning, we ensure efficient IRB approval and maintain study deadlines.
With our experienced team of Clinical Trial Liaisons, we establish strong relationships, address resourcing challenges, and accelerate recruitment rates. Our approach combines expertise with strategic planning and execution to enhance patient enrollment and retention milestones.
“Every day, I am honored to work with so many talented and passionate colleagues, determined to create clinical study awareness and improve the patient and site experience.”
Alison Bedenkop, Senior Director, Patient Recruitment and Retention
As a result of the pandemic and ever-improving technologies in the healthcare space, Decentralized Clinical Trials (DCTs) are steadily gaining traction. However, there is some general confusion across the industry surrounding DCTs.
DCTs have significant potential to enhance data quality and patient recruitment and retention. Adopting DCTs can alleviate site and patient burdens, resulting in improved enrollment and patient access to research, which can allow your study to move forward.
Our consultative approach considers protocol, regulatory, and operational aspects to ensure a successful trial. With guidance from our accessible senior leaders, you’ll have a full understanding of the pros and cons of adopting DCTs for your specific study.
We also offer realistic solutions tailored to your study’s needs, focusing on flexibility and customization. As a tech-agnostic partner with established relationships, we integrate multiple providers’ solutions to align with your study protocols. We emphasize seamless integration between tech and operations, complemented by our Clinical Assessment Technology (CAT) team, which utilizes ePRO and eCOA.
By leveraging our objective and comprehensive approach, you can gain clarity on DCTs, receiving personalized recommendations and optimized solutions for your study.
“From the executive level to our newest employees, I can always count on someone for support, guidance, and insights to help me to succeed in my role.”
Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies
With the implementation of ICH’s General Considerations for Clinical Studies, adopted in October 2021, it’s more important than ever to emphasize patient safety and data integrity. At Worldwide, we utilize a holistic and proactive approach to identify potential safety concerns, maintaining patient safety as our top priority.
Our risk-based quality management (RBQM) strategy skillfully combines risk management, central monitoring, and on-site monitoring. We customize our approach for each study, engaging in upfront scenario planning and providing options to address potential risks. We proactively assign quality tolerance limits and pre-identified action plans for different risk levels, staying consistent with ICT and other guidelines.
With our significant industry expertise in RBQM, you can trust that your study is in capable hands. Our risk managers have an average CRO experience of 10 years, while our central monitors have six years. In addition, our RBQM specialists have an average of 4.8 years of experience in risk management and 3.6 in central monitoring.
At Worldwide, we prioritize early signal detection and provide early warnings for potential issues, giving you the confidence you deserve in your data quality. With our risk mitigation strategies, you can rest assured that your study will stay on track and be managed by professionals dedicated to patient safety and data integrity.
“The most exciting aspect of my role is contributing to revolutionizing how we approach the planning and conduct of clinical trials.”
Amandeep Sonik, Director, Risk Based Quality Management