Powerful Insights-driven Technology Platforms to Transform Your Clinical Development
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 work with the best-in-class software providers to bring-in next-generation technology to optimize your clinical development path.
Clinical Technology Solutions & Services
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.
Our clinical team has the expertise to execute the following activities:
- Rapid EDC Study Database Setup (Visits, Subjects, Forms, Logs, etc.)
- Configure eConsent in EDC Platforms with local language translations
- Edit Checks Programming for Data Cleaning (Univariate & Multi-variate)
- Completing mid-study changes in the EDC platform with minimal downtime
- Setting up Medical Dictionaries (MedDRA, WHO-Drug, SnoMed)
- Establishing system integrations with ePRO, eCOA and other eSource data
- Facilitating data export and creating custom reports for tracking DM metrics
Our EDC Systems Expertise
> Oracle Clinical / RDC / TMS
> Clinion
> Viedoc
> Medidata Rave
Explore Our Solutions
Electronic Data Capture, eConsent & RTSM
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.
Clinical Trial Management System & Site Payments
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.
Collaborative PVA Review and Approval
Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures.
SLA Definition and Tracking
Configure multiple Service Level Agreement measures for each agreement to track partner's activity timelines and overall compliance adherence
Integration with Exchange Tracker
Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker.
Automated Safety Data Exchange Reconciliation
Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards.
Correspondence and Collaboration
Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners.
Process Alerts & Notifications
Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.
Process Insights & Partner Oversight
Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight.
Solution FAQs
We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations.
Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
