Clinical operations can slow your journey to market; Excelya’s expert team can optimize your clinical monitoring, manage vendors and improve efficiency to accelerate your process and reduce costs.
A clinical trial can be fast-paced, and as you go through the process, unexpected risks can delay your progress, costing you time and money. With a partner that can bring expertise and the agility to apply it when it’s most needed, you can overcome these barriers.
With strong support for clinical monitoring and other operations, your trial becomes more stable and resilient. Greater efficiency means faster results and a smoother journey to market, benefiting you and the patients you aim to help.
At Excelya, our talent pool of 400 clinical monitoring and project management experts have the capabilities you need. Our clinical research associates (CRAs) and lead clinical research associates (LCRAs), clinical trial assistants (CTAs) and project managers can apply their experience across all trial phases and a range of therapeutic areas, helping you execute your trial and get your intervention to market.
A successful clinical trial is built on a clinical operations process that is run with accuracy and integrity, by a reliable and consistent team. At Excelya, we put people first. We support the long-term development of our talent pool, and our organization is structured to foster retention, giving you the reassurance of a stable project team.
We understand that clinical trials involve many different stakeholders throughout the process. Our Clinical Operations team works with a flexible people-centric approach that ensures effective collaboration, including with local and international key opinion leaders.
We keep the lines short to maximize efficiency: our team works closely with Excelya’s pivotal operational departments, such as Medical Writing, Vendor Management, Regulatory Affairs, Data Management and Pharmacovigilance. The connections are already strong, so we can deliver a trial that exceeds your expectations, fast.
When you’re running a clinical trial, your needs can change as the research progresses. To give you the best support possible, we employ flexible monitoring strategies and customize plans to meet the specific needs of your trial. Our flexible approach is data-driven, and we focus on monitoring and data quality at the site. We also use technology to enable smarter monitoring.
We begin by establishing a monitoring plan that sets out the approach in detail, for example, including the level of Source Data Verification (SDV) and the monitoring process we will follow. We deploy flexible and data-driven monitoring strategies, depending on study requirements and based on site activity and performance. We can then adjust this schedule depending on factors like recruitment and risks identified.
Excelya’s expert CRAs follow the monitoring process to verify that sites are adhering to the protocol, help resolve queries and close any pending action items. They focus on several elements, including: critical data, subject eligibility, protocol deviations and data critical to subject safety, the endpoints of the study, and the reliability of the findings.
Regular communication is a vital element of our approach. Our CRAs meet with investigators in person at the end of each visit to discuss any findings and recommendations, such as re-training needs.
Successful clinical operations require the capabilities that come with a large broad-scope team and the agility and energy that a small group can bring. At Excelya, our size enables us to fulfil your needs on small and large scale projects, while giving us the flexibility to meet your evolving needs as changes occur.
This scalable resourcing means you can build the bespoke support you need. From clinical monitoring support with a single CRA, to a clinical monitoring platform across multiple countries, our flexible Resourcing, Functional Service and Full Service delivery platform can help you close the operational gaps in your trial.
You can also choose to extend your clinical monitoring reach with Excelya, for example, as a European regional extension of a US-based trial.
Project management can be a complex aspect of a clinical trial, especially when you are working across geographic areas and with multiple teams. With hundreds of expert project managers, Excelya has the capabilities you need to ensure efficient project management.
Project management support from Excelya can propel your operations all the way to post-market. You can tap into our expertise at every stage of clinical operations, from feasibility and study design, through regulatory submission and vendor management to patient recruitment and pharmacovigilance.
Our services are designed to make sure your clinical operations run smoothly from start to finish, including:
Your clinical trial can involve many different vendors, from laboratory services and bioanalytics to home nursing. Finding vendors that align with your objectives and managing them in a way that maximizes efficiency and reduces costs can optimize your clinical trial.
At Excelya, we make sure all your vendors work together to achieve your goals. Our dedicated vendor management professionals – called Contributors – specialize in each activity your vendors undertake, including:
Excelya teams work according to our Vendor Management and Oversight (VMO) model, which we apply in trial operations. Each Contributor is specialized in managing activities in their area across studies, ensuring the vendor works efficiently on your trial. They also have a cross-disciplinary view across multiple therapeutic areas, and they collaborate with colleagues in the study team and beyond.
As members of the Excelya team, Contributors have flexible working patterns so they can cover multiple time zones. And as they are Excelya employees, we will indemnify clients against co-employment risk.
Case Study: Top-5 Pharma Company
Excelya provided a comprehensive central services solution for clinical studies with this top-5 pharma company. We managed 10 vendors for 90 studies from set-up to close-out.
We assessed all vendors and scope of work to harmonize resources and reduced study costs by 16%. In the first 18 months, we optimized time spent by 10%; within 18 months, we had optimized by another 10%.
