Resources
Pharma Initiatives produces white papers, case studies and webinars to discuss challenging issues facing our clients. Pharma Initiatives also produces a blog focused on Medical Affairs operational issues. Links to white papers, case studies, past webinar videos, upcoming webinar registrations and our blog are found below:
Webinars
Successful ICH E6R(2) Implementation Webinar
ICH E6(R2) is now GCP. For a Sponsor or CRO, implementing the risk identification and management components of E6(R2) successfully in your clinical development operations can be challenging. The temptation exists to treat this as a software implementation and trust automation vendors to drive the process change. That would be a mistake.
This webinar focuses on successful E6(R2) implementation, explaining why taking a software agnostic approach is more effective at this time. It will include best practices from the experience of Pharma Initiatives Consulting, as well as the practical experience of Rho, Inc. - a mid-sized CRO which has successfully implemented these changes.
CENTRAL MONITORING: A Practical Guide Webinar
ICH E6(R2) has ushered in an era of risk-based quality management (RBQM). Yet, many sponsors struggle with the aspect of RBQM that drives the most value - Central Monitoring. Pharma Initiatives has developed a practical guide for successful Central Monitoring based on its experience working with dozens of sponsors. In this one-hour webinar, Pharma Initiatives will share its Central Monitoring best practices, whether you control all the study execution or you outsource to CROs.
Exception From Informed Consent: 7 Keys to EFIC Study Success Webinar
Exception From Informed Consent (EFIC) studies have a distinct and challenging set of regulatory guidelines. While 21 CFR 50.24 provides the regulatory framework for EFIC studies in the US, implementing these regulations in practice is not straightforward. Pharma Initiatives has experience successfully assisting our clients through the EFIC planning and execution process. In this one hour webinar, Pharma Initiatives Partners Gary Tyson and Mark Shapiro share seven keys to success based on their experience.
White Paper
Learn about Pharma Initiative's insights into the Clinical Trial Management System marketplace which CTMS may be right for your organization. This CTMS competitive analysis was developed based on the experience of Pharma Initiatives gained through multiple, detailed CTMS selection and implementation projects.
Case Studies
Clinical Development
Clinical development leaders had a strategic goal to develop protocols more rapidly. PI created a Strategic Playbook that redesigned the protocol development process with quality and speed, eliminating lost time and clarifying ownership. Then PI and the client partnered to implement the Strategic Playbook and achieve the client's goals – protocol cycle times reduced by half.
Medical Affairs
Medical Affairs leaders at a large pharmaceutical company had a strategic goal to more effectively engage with access and reimbursement.
PI created a Strategic Playbook that included recommendations for a new field organization, modified processes for the existing field force to better share insights, and a new approach to post-marketing research.
Then PI and the client partnered to implement the Strategic Playbook and achieve the organization's goals including a 75% increase in MA support of formulary presentations and a 50% increase in access and reimbursement involvement in post-marketing research.
Commercial
EU commercial leadership had a strategic goal to increase sales of a follow-on product by improving sales team scientific knowledge. PI created a Strategic Playbook that created a new approach to sales education, measurement of sales staff knowledge and technology to support sales. Then PI and the client partnered to implement the Strategic Playbook and achieve the client's goals – exceeding sales targets by 50% in the six months following implementation.
