Clinical trial start-up timelines have slowed in recent years, and pharmaceutical sponsors need solutions to help sites get activated more quickly and consistently around the world. They need leading-edge tools that make activation tasks and communication easier for sites. Increasingly, companies are looking for comprehensive solutions that mitigate the driving forces behind delayed study launches without burdening sites with disconnected technologies.

In the recent webinar, Practical Approaches to Faster Study Start-ups: Making Progress in the Face of Industry Headwinds, industry leaders from Novartis Pharmaceuticals and IQVIA R&D Solutions (RDS) explained how they use innovation from IQVIA Technologies (formerly DrugDev) to accelerate site activation. Here's a summary of what was discussed.

Keep Sites Organized And On Track

Sites preparing to launch a new study are often overwhelmed with information and documentation. Reliance on email and desktop folders means that sites risk misplacing documents and must wait for information or to receive help when they have questions. The Investigator Site Portal from IQVIA Technologies is purpose-built to streamline communication between sites and sponsors while protecting proprietary information. It enables sponsors to provide a dedicated place for sites to access the documents and information they need, submit questions, and interact with subject matter experts.

IQVIA RDS and Novartis use the IQVIA Investigator Site Portal (the Portal) to create a consistent experience across trials, exposing the precise documentation that sites need, when they need it, customized by country and region. They equip sites with the right tools to maintain momentum so communication delays do not slow down activation.

The Portal is best utilized when study teams view it as a collaborative tool rather than mere document storage. For instance, submissions management functionality allows sites to actively track each required task through the regulatory submissions and approval stages, distributing reminders and alerts to stay on track. Tools such as these empower sites to participate as stakeholders throughout the activation journey.

How Novartis Empowers Sites

Novartis Pharmaceuticals provides sites with a consistent experience with the IQVIA Investigator Site Portal, branded as Novartis Connect, across all its trials. Before employing Novartis Connect, the company would wait for contract approval before talking to sites, prolonging study start-up. Now, they use the Portal to accomplish tasks while waiting for approval. For example, they can proactively create templates for similar documents across sites, such as contracts or legal materials, and save them in the Portal for distribution.

Likewise, they can use the Learning Management System (LMS) module within Novartis Connect to set up training courses so that site staff are fully prepared for activation as early as possible. They use the Portal to track trainings and even apply for cross-trial training credits rather than be taxed for repeatedly completing the same training program for different studies.

IQVIA RDS similarly seeks opportunities to leverage the Investigator Site Portal during the site activation period. Sites are then fully equipped to start enrollment, with efficient access to study materials throughout the trial.

Making Progress In The Face Of Headwinds

Of course, technology must be supported by a strong organization and processes. As protocols and studies become more complex, offering sites in-depth expertise and guidance to keep moving forward is more important than ever.

Novartis has deployed study start-up specialists to work directly with sites during activation and develop a strong relationship with them. For example, if a site is in the European Union, Novartis assigns a specialist in EMA guidelines to assist with site activation. They also designate a single point of contact to interact with the site for help and accountability.

Access to self-service support is also essential. Novartis compiles an ongoing list of frequently asked questions in Novartis Connect, where sites use full-text search to find answers to common issues, saving them the time of writing queries and waiting for companies to respond.

Tools such as the IQVIA Investigator Site Portal combat the headwinds slowing down site activation across the industry. High satisfaction with the Novartis Connect platform shows companies can streamline activation tasks, improve their relationships with sites, become a sponsor of choice, and launch their clinical trials faster than their competitors.

About The Author

Rosemary Shirey is the Associate Director of Client Services for IQVIA Technologies. Rosemary has more than ten years of experience working within the clinical research space and currently leads Client Services for the IQVIA Investigator Site Portal (formerly DrugDev). She supports and collaborates with sponsors and CROs, helping their study teams start up and conduct trials more efficiently by applying technology in innovative ways to solve site challenges. Rosemary graduated from Harvard University with a degree in History and Science.

About the Contributor

Raphaëlle Gilg is the Strategy and Operations Manager for Novartis Pharmaceuticals. Raphaëlle started her career as a nurse in cardio intensive care units. With a passion for novel ways of treating patients, she naturally switched gears to clinical research, first becoming a Clinical Research Associate and then moving into different roles across the industry. Raphaëlle leads Novartis Site Engagement from the Business Operations side, striving to establish positive and efficient site-sponsor relationships, continually addressing study start-up and site initiation timelines, and finding solutions that empower study teams to access key documents and information quickly, removing administrative burden.