Clinical Trial Monitoring and Site Activation Services, Working Side-By-Side to Create a Healthier-World
Pharm-Olam operates in 60+ countries, supporting our sponsors on all major continents with the ability to deploy experienced resources where you need us. Our Clinical Operations group consists of two departments, Clinical Monitoringand our Global Site Activation Unit.
Clinical Trial Monitoring Services
Clinical Research Associates (CRAs) are an extension of you, the Sponsor, and you need them to properly represent your organization to physicians [investigators] around the world involved in your clinical trials. You also need them to be knowledgeable, effective, well-trained, quality and safety minded while being focused on the sites and patients in your clinical trials.
From the beginning, our CRAs are working on the front lines of your study. We promise to work side-by-side with you to help create a healthier world, together. CRAs are critical to the clinical trial ecosystem. To keep your study running smoothly, CRAs must have the expertise to handle a multitude of issues quickly and efficiently. Our clinical trial monitoring team is primarily made up of physicians or Ph.D.-level personnel, and our CRAs average more than six years’ monitoring experience.
Because our clinical trial operations team has the experience and know-how needed, your study is supported and optimized to perform at the highest possible level every day.
CRAs with Therapeutically Deep Expertise
End-To-End RBM Strategies for Effective Clinical Trials
Comprehensive risk-based monitoring (RBM) strategies and technology are vital to the success of your clinical trial. We also support your study by making sure your strategy meet RBM functional requirements as outlined in part two of TransCelerate Biopharma’s RBM Technology Considerations. Our cross-functional teams evaluate your study protocol to further identify risks using our Risk Assessment Categorization Tool (RACT), and integration into Pharm-Olam's leading bow tie risk management system.
A holistic, end-to-end RBM strategy needs the right technology to support it. Pharm-Olam leverages Medidata's Rave Clinical Cloud to power our clinical execution and RBM strategies. Medidata's Rave Clinical Cloud leads the industry, it captures data from a all study data sources such as EDC, eDiaries, central laboratories, imaging documents and brings it into one unified platform for data aggregation and analysis.
From start to close, our clinical operations team works with you to ensure the RBM strategy for your study is fully able to identify and manage risks and provide the highest data integrity. To learn more about how Pharm-Olam is Powered by Medidata, click link below.
Pharm-Olam's Global Site Activation Unit (GSAU), maintains a team dedicated to guiding expeditious clinical trial site activation. With global start-up leads and local teams, the GSAU team provides the following:
Site Activation Management
Site Contract & Budget Management
Essential Document Management
To learn more about our Global Site Activation Unit and their services, click the button below.
Having a large global reach across more than 60+ countries around the world means that your study receives the customized geographical support it needs. Our scalable delivery ecosystem includes a vast network of personnel, sites, partners and three Centers of Excellence. This gives your study the advantage of having the right people in the right locations to provide the specialized knowledge and solutions to manage your study successfully.
In addition to our Centers of Excellence, Pharm-Olam offers our Expeditionary CRO service model to extend the reach of your study even further by providing access to remote or developing countries and regions (Africa, South America and Asia Pacific).
Pharm-Olam as part of our scalable delivery ecosystem can also provide a functional service provider (FSP) solution for CRA coverage to ensure all your monitoring needs are met.
Demonstrating Our Culture of Accountability In Clinical Operations
Pharm-Olam’s Culture of Accountability, another key element within our Pattern of Excellence, means that you can count on our teams to take ownership for their work and that of the sites and vendors involved in your clinical trial. Because our CRAs are empowered to make decisions and provide solutions, your study is positioned for success.
When a site falls behind in enrollment or a vendor suffers a issue, we do not point fingers. We work together, side-by-side, to resolve the situation with our Sponsor and the involved parties. Clinical Trials are like an ecosystem and it takes a team approach to make them thrive.
By taking ownership and responsibility for the success of your study, we deliver on our promise to demonstrate our pattern of excellence in every service we provide.
To learn more about our Pattern of Excellence, visit our Why Pharm-Olam page.