Leverage our AccelCTMS Solution to Seamlessly Plan, Execute, Track and Report All Clinical Trial Activities
AccelCTMS’ is a fully-managed, cloud-based integrated clinical trial management solution offered by Techsol using Oracle Siebel CTMS and Oracle Clinical Data Analytics applications. Our solution enables holistic management of critical clinical trial activities from study start to site close-out for global studies. Emerging biopharma, device manufactures, and contract research organizations can leverage AccelCTMS to plan, manage and track early to late-stage clinical trials.
Solution Benefits & Business Value
- Establish a single source of truth for all clinical trial activities
- Avoid costly delays due with proactive project risk management
- Streamline stakeholder information across the clinical trial ecosystem
- Gain actionable insights across study milestones to take informed decisions
- Increase operational efficiency by eliminating redundant manual trackers
- Achieve superior process quality and 100% regulatory compliance
AccelCTMS – Key Features & Capabilities
Clinical Study Planning
Proactively Plan for Conducting Global Clinical Trials
Track Protocol Development & Regulatory Submissions
- Manage and track multiple clinical programs and associated clinical studies
- Track the statuses of all study related regulatory documents to plan for submissions
- Track Regulatory submissions and approvals and get timely notifications on pending issues
Perform Budget Planning & Allocation
- Plan and forecast trial budget with the Project Costing Module
- Execute budget allocation to study teams with global or local currency
Complete Sites, Investigators & Vendor Selection
- Track Sites and Investigator Qualifications for Trial Participation Eligibility
- Define new vendor contracts and track contract execution
- Select existing vendors based on past performance
Rapid Clinical Study Startup
Timely initiate a Clinical Study Across Sites and Investigators
Project & Resource Management
- Identify study team at various regions and pre-assign to specific regions and sites
- Perform Resource Allocation based on system generated work load metrics
- Define activities, timelines and targets for team members
Sites & Investigator Selection
- Perform Site Evaluation & Feasibility Analysis
- Perform Investigator selection based on past performance
- Plan for Investigator Meetings
Manage Study Go-LIVE
- Plan for Site Initiation
- Track IMP Dispensing
- Track Contract Payments
Clinical Study Conduct
Establish Comprehensive Operational Oversight throughout the entire clinical trial duration
Site Visits Management
- Prepare site visit activity templates & plan site visits
- Define, update and track site visit activities
- Track and maintain site specific study documents
Subjects Tracking
- Define Subject Visit templates
- Perform CRF tracking
- Monitor trial progress of subjects
Clinical Supplies Management
- Define activities related to clinical supplies
- Track drug accountability
- Manage clinical supplies demand management
Payments Tracking
- Investigator Payments
- Site Payments
- Subject Reimbursements
- Vendor Payments
Study Closure
Gain comprehensive insights on the clinical study with built-in reports and dashboards
Sites Closeout
- Proactive Planning for Site Closeout Visit
- Define, Update and Track Site closeout Visit Activities
- Track Drug Accountability
- Complete pending payments
Study Documents Archival
- Site specific essential documents reconciliation
- Trial Master File Documents Archival
- Update and closure of Contracts and Agreements
Stakeholders Performance Assessment
- Investigator Performance Assessment
- Site Performance Assessment
- Vendor Performance Assessment
Reporting of Clinical Study Outcomes
- Generation of Trial Summary Reports
- Reporting of Study Budget Expenditure
- Clinical Project & Program Outcomes Review
Additional Information
To enable smooth clinical operations & improve clinical trial data quality, AccelCTMS Plus has prebuilt Risk-based monitoring capabilities where clinical study sponsors can define a comprehensive set of Key Risk Indicators (KRIs) to identify potential study data factors that will require risk management, from trial planning through analytics.
Our solution can identify risk areas for a drug, and adjust for it, based on the results per trial. It can then rollup those results and provide deeper insights on the full trial risk at the program level.
AccelCTMS is delivered on a GxP compliant fully-managed cloud platform where all ongoing systems validation and preventive maintenance will be managed by Techsol throughout the business lifecycle.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
