Techsol specializes in providing integrated GxP compliant, ready-to-use software platforms for sponsors to streamline data collection, stakeholder collaboration, oversee business processes and gain insights across the clinical development lifecycle.
We help sponsors to leverage the best of integrated Electronic Data Capture platforms to facilitate accurate clinical data collection with built-in medical coding, source data verification, discrepancy management and faster query resolution.
What are the EDC Platforms that we provide?
As an Oracle Partner, we specialize in delivering end-to-end study database management services using AccelClinical which is packaged with Oracle Clinical, Oracle Remote Data Capture, and Oracle Thesaurus Management System.
Additionally, we also have a team of certified professionals who can setup the study on Oracle’s Clinical One platform which has built-in Randomization & Trial Supplies capabilities.
How can Techsol help with long-term PMS Studies?
For Observational Studies, Registry trials and other PMS studies, we help pharma and medical device companies to leverage our cost-effective Compier PMS platform which has got all the functionalities to facilitate seamless data capture.
Introducing 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.
Emerging biopharma, device manufactures, and contract research organizations can leverage our AccelCTMS cloud solution to plan, manage and track early to late-stage clinical trials. It enables holistic management of critical clinical trial activities from study start to site close-out for global studies.
Key Benefits
- Leverage a ready-to-use, pre-configured CTMS solution that can be aligned to your processes
- Maintain a centralized clinical sites and principal investigator database
- Provide users with relevant and timely information through alerts & notifications
- Provision trial information to clinical research associates and managers
- Enable transparent tracking and reporting of clinical trial activities
- Facilitate communications to the study team
Establish Clinical Trial Efficiency Using AccelCTMS
- Leverage a centralized trial management database for all investigators
- Provide users with relevant and timely information
- Provision trial information to clinical research associates and managers
- Enable transparent tracking and reporting of clinical trial activities
- Facilitate communications to the study team
If your organization is using Veeva eTMF, our team can support in the following areas:
Veeva eTMF System & User Administration
- User Roles & Permissions Management (Internal & External)
- Addressing user security issues
Object & Workflow Configuration (Person, Site ,Organization , Study Hierarchy and Milestones)
- Document Fields Applicability Determination & Configuration
- Document Naming Convention Setup
- Designing sub-artifacts to accommodate new sub-classifications
- Milestone specific document completeness checklist configuration
- Setup picklist visibility as per user role
API-based System Integrations
- Auto-populating Trial documents from other applications
- Completing bulk upload of documents using Veeva Loader
Veeva eTMF Technical and Functional Support
- Complete new eTMF Setup that is aligned to the TMF Reference Model
- Assisting end-users on eTMF functionality
- Tracking expected documents for each milestone (Inspection Readiness at Study/Country/Site)
- Performing Study Archival
- Supporting users to make selective changes in document content and metadata configurations
- Troubleshooting and resolving functional application issues
- eTMF Change Management
- New release enablement
- Completing configuration changes
- Delivering training to end users on new functionality
- Assist user acceptance testing and deployment
- TMF oversight & health monitoring for staying audit-ready
As a partner of Clario, we have our team of experts to deliver simplified eCOA and ePRO solutions based on study specific needs for different therapeutic areas. Following are some of the key areas where we can add value:
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Clinical Oversight involves proactive management of quality, risk and compliance across clinical trial activities, stakeholder engagement, vendor performance reviews, staying audit ready and derviving value at every opportunity by reducing timelines, cost and increasing productivity.
At Techsol, we have engineered Compier a cloud-based oversight platform which has built-in KxIs (Quality, Performance, Risk, Compliance) to provide comprehensive insights across your clinical programs. Compier supports both upstream and downstream rapid system integrations, with a built-in inbox module and next-generation analytics.
How We Can Help
We have worked with sponsors to deliver e-submission ready SDTM compliant data sets as per the specifications laid out by the Clinical Data Interchange Standards Consortium (CDISC) group.
Our Areas of Expertise
- CRF Design as per CDASH standard
- CRF Annotation as per SDTM convention
- Study database setup using SDTM variables
- Raw study data sets transformation to SDTM datasets using SAS
- Define.xml creation & validation
Let us Know on How We can Help You
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