Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight

Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs. 

Common Challenges faced by MAH Representatives

  • Inefficiencies in identifying suitable partners and vendors without a centralized partner database
  • Lack of historical performance measures to qualify partners and vendors for future engagements
  • Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates
  • Delays in completing the agreement review and sign-off with manual sharing of documents
  • Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence
  • Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections

Introducing Compier Agreements

Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance.

Solution Features & Benefits

Business Discussion
Centralized Partner Data Management

Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place. 

Templatized Digital PVA Authoring & Versioning

Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions.

eConsent for Clinical Trials
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.

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    Simplifying Regulatory Affairs from Product Development to Commercialization

    The Regulatory affairs function in the pharmaceutical industry has a huge responsibility to ensure that new medicinal products are developed, manufactured, and marketed in compliance with global and regional regulatory requirements. 

    In recent times, Pharma companies and  Life Sciences organizations are challenged with an increasingly complex regulatory landscape that has evolved dramatically to ensure better public health with a laser focus on patient safety, product efficacy, quality, risk management, transparency, and compliance.

    Our Global network of Regulatory Center of Excellence will provide the services for all major markets such as – North America, Europe, Middle East, LATAM, Africa and Asia Pacific. Techsol’s Service Delivery Centers are located in US, South Korea, EU and India.

    Our Capabilities

    With over 15+ years experience, our regulatory professionals have helped several pharma and medical device companies by delivering clinical, non-clinical, and post-marketing related regulatory services.

    Following are some of the key areas of where we provide specialized regulatory knowledge and operations support.

    Regulatory Agency Liaison | Techsol Life Sciences

    Submission Preparation

    Assist with the preparation of regulatory submissions, including new drug applications (NDAs), investigational new drug (IND) applications, and marketing authorization applications (MAAs).

    Regulatory Strategy

    Support sponsors to develop and implement regulatory strategies, including identifying and addressing regulatory risks, determining the optimal regulatory pathways for approval.

    Regulatory Intelligence

    Provide regulatory intelligence and guidance on emerging regulations, changes to the regulatory landscape, and the latest regulatory trends for drugs, biologics and medical devices.

    Regulatory Operations

    Manage the day-to-day operations of the regulatory function, including document management, submission tracking, and interactions with regulatory agencies.

    Post-Approval Support

    Support ongoing regulatory needs after a product has been approved, including ongoing regulatory compliance, label updates, and periodic reporting requirements related to product safety.

    Global Regulatory Affairs

    Offer global regulatory consulting expertise in specific regions and therapeutic areas, as well as support for cross-border regulatory submissions and Health Authority interactions.

    Our Regulatory Affairs Services

    At Techsol, our expert team of Regulatory Affairs professionals  have extensive expertience to support end-to-end sevices throughout the product lifecycle of drugs, medical devices, and other healthcare products. 

    We provide the following services focused on supporting companies as they advance their drug, biologic, device, and/or combination products through regulated pathways from development to commercialization.

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