THOUGHT LEADERSHIP

PROMETRIKA, LLC. is a full-service CRO whose clients include national and international biopharmaceutical and medical device companies. In the clinical research environment, even “simple” studies become significant projects spanning multiple companies, teams, investigators, and regulatory bodies. Given such complexity, our Project Managers (PMs) are critical to effective management of all services and functions that contribute to the success of a project.

As a Clinical Project Manager (CPM), one of my primary roles on a project is to ensure that the clinical and data management stakeholders have the tools necessary to streamline safety review and data quality review on a project. The CPM’s first action should be to complete a Stakeholder Analysis. According to the Project Management Body of Knowledge (PMBOK), Fifth Edition, released by the Project Management Institute (PMI), the key processes in Stakeholder Management are:     
                                                     1. Identify Stakeholders
                                                     2. Plan Stakeholder Management
                                                     3. Manage Stakeholder Engagement
                                                     4. Control Stakeholder Engagement
Knowing who the stakeholders are, and how and when to engage them in the development process of a clinical application, can lead to major improvements in product usability and ultimate project success. 

PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications such as oncology, CNS/psychiatry, renal disease, respiratory disease/allergy, and several rare diseases. PROMETRIKA’s NDA/MAA Project Managers (PMs) have developed the tools and skills necessary to successfully manage the study level team and the subject matter experts to complete submission projects with high-quality, on-time deliverables.