Overview of AccelCTMS

‘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.

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.

AccelCTMS Solution Models

With AccelCTMS, customers are given the following solution models each of which has a host of feature functionality choices to plan, manage and fully track all clinical operations activities.

The add-ons of having system integration with EDC and eTMF are open choices we offer to customers irrespective of the solution model. But the advanced Risk-based Monitoring with KRIs & the reporting modules are available only with the AccelCTMS Plus edition.

Solution Feature AccelCTMS AccelCTMS Plus
Program & Protocol Management
Study Budget & Expense Tracking
IP & Document Tracking
Site Management
CRA Site Visit Trip Reports
Subject Recruitment Tracking
Investigator Payments
Study Performance Tracking
CRO Data Collection
eTMF Integration Add-on Add-on
EDC Integration Add-on Add-on
Risk-based Monitoring with Key Risk Indicators (KRIs)
230+ Pre-built Reports and dashboards for Trend Analysis with KPIs
Milestone Tracking & Risk Alerts

What are the unique solution capabilities of AccelCTMS?

AccelCTMS can be tailored with flexible configurations in alignment to your clinical trial management business process. At a broad level, our solution can fully address the core activities involved in following clinical trial milestones with the prebuilt application features & modules.

Clinical Study Planning Study Startup

Protocol Development

  • Manage and track multiple clinical programs and associated clinical studies
  • Track Regulatory submissions and approvals

Budget Planning & Allocation

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

Vendor Selection

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

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
Study Conduct Study Closure

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

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

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.

  • Fast track implementation with phased approach for global roll-outs
  • Continuous guidance from SMEs for business process design
  • Business-user training (Train the trainer, Classroom, Remote)
  • AccelCTMS is pre-validated with IQ/OQ and is UAT ready
  • 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
  • 24×7 Technical & Functional support (Requests, Incidents, Change)
  • Preventive Maintenance & Cloud Monitoring
  • Technical support for ongoing configurations management
  • Functional support for troubleshooting business workflows

Why ‘AccelCTMS’ is an ideal choice for Clients?

Key Business Benefits

AccelCTMS offers the following advantages to sponsors:

  • Easily implement strategic, risk-based monitoring to improve study data quality
  • Make fast and accurate decisions with real-time subject enrollment and site performance metrics
  • Facilitate multi-channel communications and compliance through automated workflows and notifications
  • Improve investigator targeting and subject recruitment to achieve target study dates with built-in investigator intelligence
  • Increase process efficiency and staff productivity at clinical sites through comprehensive performance analytics and mobility

With real-time visibility into clinical trial progress, Sponsors can establish improved relationships with vendors and principal investigators by having a centralized database for maintaining, tracking and sharing:

  • Site Contact information
  • Qualification of key study team personnel
  • Clinical staff resource utilization
  • Clinical trial contracts & payments progress
  • Study documentation status