Clinical Operations is the quintessential part amidst stakeholders
COD Research Clin-Ops team is in the thick of action that kick-starts clinical trials. Carrying out clinical trials is cross-functional. Our Clin-Ops team regularly communicates with each group to ensure they’re up-to-date on the relevant trial information. You can think of Clinical Operations as the crucial part within the spoke of a wheel.
Planning
We prioritize certain activities while planning the study operations and minimizing the anticipated risks at the initial level. Tracking the activities with the proposed plan plays a crucial role in study success within the committed timeline.
● Feasibility
● Site Selection
● Budget negotiation and streamline with Investigator
● Execution and Tracking of Operation
○ Site Activation
○ Screening and Recruitment
○ Protocol Deviations
○ Regulatory/Audit Inspection Readiness
○ Study Timeline Management
○ Site Recruitment, Activation, and Motivation
○ Various Site Training
Site Engagement
As the name implies, site engagement keeps sites invested in the trial's outcome in an effort to improve performance across the board. In short, it helps get the most out of the sites. We create a sense of ownership among them from the beginning of the study. We inspire them through friendly competition and equip the sites with the information and tools they need to make their life easier.
● Engagement makes it easier to engage the site and sponsor
● Hasten stimulation
● Efficient Communication and conduct of the study
● Inspection / Audit readiness
● Clinical Trial Payment
Patient Engagement
Being in this industry for so long, we know that patient engagement plays a vital role in clinical trial success, impacting everything from recruitment to advocacy.
● Patient enrolment (Recruitment and Retentions)
● Patient referral strategies (Direct-To-Patient-Recruitment) for rare disease
● Patient awareness and support
● Decentralized/Patient-centric approaches to ensure ease of participation and compliance
● Supporting Technological advancements (e-diaries, wearable devices, etc.)
Clinical Trial monitoring proficiency
● The primary purpose of monitoring is to ensure that the rights, safety, and well-being of the trial subjects are protected and that the data coming out of the trial is accurate and credible.
● Clinical trial monitoring requires data collection and analysis throughout a project to ensure validity, the integrity of the data, and the protection of human subjects
● Our GCP trained Monitors help in:
○ Mitigate Risk
○ Systematize workflows to advance subject safety and compliance, Expands Study quality
○ A blended approach of On-site & Remote Monitoring
○ Uniform clinical data
○ CRA allocation
○ Pioneering approaches to stay off of regulatory change
Risk-Based Monitoring
RBM is the process through which we identify, assess, monitor, and mitigate the risks that could affect the quality of the study.
Identify latent threats: When commencing the study, we identify its critical elements. Deviation from these elements can jeopardize the entire development program. Hence we plan activities to mitigate this at each stage.
○ Design a plan to monitor those activities.
○ Our robust monitoring plan will successfully implement risk mitigation, and we believe that risk communication plays a vital role during the monitoring.
○ Acclimate monitoring methodology as required
○ Persistent risk assessment and allocation of experienced resources will help successfully implement processes.
Different models
to meet diverse needs
to meet diverse needs
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We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
