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AccelCTMS

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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.

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AccelCTMS – Key Solution Capabilities

Protocol Development

  • Manage and track multiple clinical programs and associated clinical studies
  • Track Regulatory submissions and approvals
  • Track Sites and Investigator Qualifications for Trial Participation Eligibility

Budget Planning & Allocation

  • Plan and forecast trial budget
  • Execute budget allocation to study teams

Vendor Selection

  • Define new vendor contracts
  • Select existing vendors based on past performance

Rapid Clinical Study Startup

Project & Resource Management

  • Identify study team at various levels
  • Perform Resource Allocation
  • 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

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

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
Product Overview

Reliable, Ready-to-Use CTMS Solution from Techsol

Oracle Gold Partner

Plan, Execute and Track the Outcomes of Risk-Based Monitoring

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.

How is the AccelCTMS solution delivered?

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.

Rapid Cloud Onboarding and System Setup

  • Fast track implementation with phased approach for global rollout
  • Continuous guidance from SMEs for business process design
  • Business-user training (Train the trainer, Classroom, Remote)
  • Implementation includes system configurations and reports

Solution Validation Readiness

  • AccelCTMS is UAT ready for clients for faster launch
  • Offered with 4 system environments (DEV, VAL, PROD and DR)
  • Solution is certified for regulatory compliance (21 CFR Part 11, EU Annex 11)
  • Continuous support from SMEs for PQ/UAT execution

Service Desk and Disaster Recovery

  • 24×7 Technical & Functional support (Requests, Incidents, Change)
  • Preventive Maintenance & Cloud Monitoring
  • Technical support for ongoing configurations management
  • Functional support for troubleshooting business workflows

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