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Small and Emerging Pharma Practice

Providing Advisory, Implementation, and Resourcing Services across the E2E PV Lifecycle

Advisory, Assessment, and Gap Analysis

  • Helping emerging biopharma clients understand the importance of PV and prepare the foundations for PV compliance

  • PV gap analysis and mapping of activities and timeline considerations based on current trial phase (e.g. roadmap of PV needs for the next 12-18 months until filing)

  • Develop implementation plan to ensure cost-effective planning of activities, including core/non-core sourcing considerations

PV Infrastructure and
Operations Implementation

  • Establish fit-for-purpose E2E PV infrastructure and business processes for pre-and-post approval, including technology and database needs

  • Develop clear and consistent governance pathways for Product safety issues

  • Authoring medical/scientific (RMP) and procedural (SOP) documentation

  • Vendor selection and management

Organizational Design and Resourcing Support

  • Organizational assessment, design, and implementation

  • PV capacity planning and management

  • Leverage established network of PV resources for staff augmentation to fill resource gaps both pre-and-post market

  • Support for placement of specific roles (i.e. QPPV)

PV Support for Clinical Trials through to Product Launch

  • Ensure PV compliance throughout the product lifecycle, including PV documentation to handle increasing amounts of data

  • Provide support for expanding PV related activities during phase 3 trial and beyond

  • Liaise with commercial team on product roadmap and its effect on PV activities in the product lifecycle

If you’d like more information about how Truliant could help, get in touch today.

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