FLEXIBILITY
Clinical Operations Services
Most early-phase sponsors work in an environment where the demands of clinical study conduct cannot be met by internal resources, but adding headcount is not advisable based on risk or financial considerations.
The Ciall Clinical Operations team provides critical resources to ensure both ongoing and planned clinical studies are executed in the most efficient, compliant, and expeditious manner possible.
Our Clinical Operations Services Include:
Interim Clinical Operations Leadership
We provide experts with deep Clinical Operations leadership experience to support our clients while they look for a permanent candidate. These team members will not only provide an interim solution to lead Clinical efforts but can also conduct assessments of the clinical organization to identify efficiencies and improvements, and help design and build the operations infrastructure to ensure our client’s clinical team have the tools available to help them succeed.
Clinical Trial Management
Ciall has a team of seasoned Clinical Study Managers who work with our clients from study start-up to study close-out. We can lead a study or support an existing study manager by taking over portions of the day-to-day study management activities so they can focus on overall execution of the study.
Vendor Oversight
Documented oversight of GCP Vendors is a regulatory expectation and is an absolutely critical component to running a Clinical Study. However, it is also extremely time consuming, and as such is often not done in a compliant manner. Our team supports our clients’ Vendor Oversight activities by creating Vendor Oversight Plans, documenting oversight activities, and overseeing the work of Vendors to ensure they are meeting both client and regulatory expectations.
Trial Master File (TMF) Management
The TMF is often a neglected area of a Clinical Study that can quickly become out of control. When TMFs are not maintained in real time, there is a risk of lost and unrecoverable documentation that results in a lack of inspection readiness. This situation can impact timelines and is extremely costly to fix at the end of a study. Ciall’s Clinical Operations experts support our client’s TMF responsibilities, whether the TMF is outsourced or held in-house, by helping to establish TMF structures and review TMF plans and processes. We can also develop a quality review process and conduct ongoing quality reviews based on milestones, risk and Vendor performance and provide documentation of these reviews to demonstrate oversight of this critical activity.