The client and challenge
Established in 2007, our client is a leader in discovering and creating new compounds to treat disorders in neuroscience, oncology and cardio-renal therapeutic areas. To control costs, increase retention and decrease time-to-fill for vacant positions, the client wanted to consolidate its vendor community. In addition, it was experiencing 1099 management/compliance issues and wanted a partner that could take ownership and provide visibility around the process. Our client was looking for flexible and versatile solutions to meet its fluctuating business needs.
The EASi solution
EASi Sciences and one additional vendor were selected to manage all of the support functions and clinical based resources assigned to the client’s Rockville, Maryland, and Princeton, New Jersey, locations. EASi’s solution included the following process improvements:
- Reclassifying the existing workforce and new employees into exempt full-time employee status
- Providing laptops and technical support to all resources
- Providing monthly spend and healthcare reform reports as required by the U.S. Sunshine Act
- Performance metrics to track and control cost and eliminate redundancies
- Implementing and completing performance reviews for all resources twice a year to increase retention
- Dedicated delivery manager to oversee EASi Sciences personnel
- Providing monthly invoicing with fixed weekly pricing
EASi successfully reclassified all existing resources under the newly approved business model with a 100 percent retention rate. Our solution provides the client with a solidified process for management and compliance around 1099 employees and eliminates co-employment confusion. The roles and responsibilities of EASi full-time employees (FTEs) and the EASi delivery manager are clearly defined, freeing up our client to focus on more specialized areas of their business.
Through this new partnership, we expanded our services to the pharmacovigilance (PV) department, which was also experiencing growing pains as it brought additional work in-house. Through Corrective and Preventive Actions (CAPA) proposals from U.S. Food & Drug Administration (FDA) audits and gap analysis, our client uncovered additional deficiencies with timely submissions, quality of work, outdated SOPs and under-performing vendors resulting in the creation of new departments. Needing the right personnel with the experience and expertise to start and grow new functional groups within PV was critical. The five main PV functional groups receiving various levels and fluctuating support include:
Safety data management
- Since 2014, our FTEs have been instrumental in leading an Oracle Argus platform integration and continue to provide support with system updates and debugging
- Continuous vendor management of software programmers and data management professionals within Oracle Argus and Oracle Empirica
GPV program management
- Functioning within the PV project management office overseeing process improvement, CAPA management, improved communication plans, vendor/alliance management, risk management plan (RMP) creation and inspection readiness protocols
- Our operations team is responsible for individual case processing, expedited submissions, work flow management and quality control
- EASi Sciences’ health care professionals have been trained in all aspects of GPV operations and are responsible for vendor oversight (functional service providers, domestic and off-shore), serious adverse event case processing within Oracle Argus, inspection readiness activities, therapeutic specific knowledge (CNS medications, oncology, cardio-renal and medical devices), expedited submission procedures (FDA e-submitter tools, Argus Bulk Submission, etc.), global safety reporting regulations and guidelines by region, and quality control (internally processed cases and vendor provided cases)
Global aggregate reporting
- Responsibilities included the integration and timeline management of adverse event reporting and safety updates periodic adverse drug experiences reports (PADERs), periodic safety update reports (PSURs), development safety update reports (DSURs), suspected unexpected serious adverse reaction (SUSARs) and periodic benefit risk evaluation reports (PBRERs).
Medical safety operations
- Medical review physicians: Co-authoring of aggregate reports, the design of protocol specific safety profiles development plans, RMP creation/submission, line listing review and SAE/expedited review
- Medical safety scientists: Additional research regarding global safety strategies, section-specific
aggregate reports and other key document authoring [new drug applications (NDAs), SUSAR LL, PADER, PBRER/PSUR, DSUR, etc.], literature searches, safety signal detection and the preparation of responses to safety inquiries from regulatory authorities
EASi Sciences was able to impact the PV department’s initiatives within the following areas:
- Streamlining internal/external communication plans
- Improved findings from regulatory inspections/audits
- Timely and quality submissions pertaining to individual serious adverse event case processing metrics
- More robust strategic safety profiles and risk management plans
- Line listing and SAE medical review oversight
- Safety management system Integration
- Our strategic partnership and alignment of expertise and capabilities has proven to be a valuable asset to the growth and success of our client.
Want to learn more about EASi Sciences? Contact us now.