Optimize Your Clinical Trials
Expert support for clinical trial success.
Optimize Your Clinical Trials
Expert support for clinical trial success.
Clinical Development Operations Solutions, LLC
Expert Clinical Guidance
We provide experienced-based guidance and hands-on support tailored to your clinical trial needs. We help you optimize the planning, execution, and delivery of phase 1-3 clinical trials.
Innovative Solutions
With a focus on solutions, Clinical Development Operations Solutions, LLC, can support your needs related to trial execution, operational efficiency, regulatory compliance, patient safety, site management, vendor management, and cross-functional team alignment to help ensure successful delivery of your clinical trials.
Consulting Services
Clinical Trial Design and Planning
We can assist you in the design and development of study protocols, recommend outsourcing and resourcing strategies, define patient recruitment strategies, develop trial plans, and establish timelines and milestones based on corporate goals.
Vendor Management
We can assist with all aspects of vendor management from RFP/RFI development to vendor selection, contracting, performance management, and oversight through delivery. Recommendations are based on your project specific needs from phase 1 units to central and bioanalytical laboratories, full-service CROs to service-specific support such as TMF and TMF administration, IWRS, scientific leadership, regional trial conduct, etc.
Project and Trial Management
We can manage or oversee clinical trials and trial-related processes from site selection to study materials development. We can also develop and manage or facilitate study and site budgets, data cleaning timelines, risk management activities, and protocol deviation management.
Regulatory Compliance
We can help you ensure adherence to Good Clinical Practices (GCP) and other relevant regulatory guidelines and provide CAPA management support as well as inspection readiness support throughout the trial.
Data Management
We can provide guidance on data collection, cleaning, and analysis to ensure data integrity and quality, advise on site-specific training needs based on data entry and protocol deviations, and conduct endpoint or comprehensive data review.
Clinical Monitoring
We can facilitate implementation of risk-based clinical monitoring plans and tools to ensure robust monitoring procedures that help identify and manage adverse events and monitor study conduct.
Site Management
We can support clinical trial sites with trial and GCP training and liaise with your medical team to further engage investigators and their teams. We can proactively support sites with training needs to mitigate issues as relevant to data entry and trends in protocol deviations and study conduct matters as identified by through monitoring.
Operational Efficiency and Continuous Improvement
We can help you identify and implement strategies to develop or streamline processes, ensure regulatory compliance, reduce costs, and improve trial execution.
Additional experience-based examples of support we can provide:
· Assistance with developing clinical aspects of Regulatory Submissions
· TMF vendor selection, management, and oversight, including inspection readiness
· Fit-for-purpose process development and maintenance
· Project and program team organization – chartering, RACI development, outsourcing strategies, job description authoring, team or individual mentoring, coaching or support, long-range planning
· Establish vendor governance
· Site and vendor corrective and preventative action management
· All-in study budget development and maintenance
· Study/program supply and enrollment forecasting
· Portfolio-wide protocol deviation management
· Establish and maintain study risk management processes
· Inspection readiness support
· Monitoring oversight
· Role-specific training/onboarding plan development
· Cross-functional collaboration to develop clinical operations’ SOPs
· Investigator Meeting Planning