“You know a consulting relationship is successful when the expertise provided is not just another service offering, but represents a vested desire to advance the client’s clinical research.” – Jennifer A. Elder, PhD, Chief Scientific Officer
The cornerstone of PharPoint Research is our consultants’ expertise, which is based on their involvement in multiple successful development programs. By listening and understanding our clients’ product development goals, we deliver a decisive plan that will optimize cost containment, minimize redundancy, reduce project timelines, and achieve short and long-term goals.
At PharPoint, the essence of customer service is listening. We listen actively to our clients and take their challenges seriously. As part of this process, we provide strategic and risk mitigation planning to deliver objectives on an agreed-upon timeline.
Our consultants will advise you through the implementation process or we will take an active role initiating change through our own functional teams, if contracted to so.
Our Consulting Services
Clinical Development PlanningOur team of clinical operations, regulatory, and statistical consultants will design a customized clinical development plan to thoroughly and efficiently evaluate the risk/benefit profile of your new chemical entity or new indication for a marketed product. As a part of this service, we will estimate the costs to execute the plan as well as provide a timeline for regulatory submission.
Within each protocol development stage, we will provide a customized strategic plan to address site selection, data collection activities, and trial risk management considerations, and analysis and submission to regulatory agencies.
Global Operational StrategiesUpon in-depth analysis of your organization’s global development objectives, we will create a detailed multi-national development plan to support operationalization. PharPoint strategically partners with international organizations of similar size that embody our quality first vision and customer friendly approach. These strategic partners offer regional regulatory and functional expertise in an international arena which allows PharPoint’s best-in-class culture to extend beyond US borders.
Regulatory Submission SupportWe provide our clients with comprehensive consulting and FDA submission services throughout the development continuum. Our PhD level professionals provide analytic services that include regulatory meeting support, special protocol assessments (SPAs), performing exploratory data analyses, and data standardization. In addition, we have extensive experience in Data Monitoring Committee organization, meeting administration, and charter preparation.
CRO Oversight and Trial SupportIs your trial under-performing? An intervention from PharPoint will get things back on track. All of PharPoint’s clinical, data management, and statistical consultants have at least 15 years of CRO experience and excel at creating and implementing solutions for timelines, effective communication and data quality to achieve the best possible outcome based on your trial objectives.
Safety AssessmentPharPoint recognizes the importance of identifying and analyzing adverse events throughout the clinical trial life cycle. Our experts specialize in medical monitoring, safety management and pharmacovigilance to ensure quality collection, evaluation, and submission of safety data. Communication and collaboration are key to our approach to strategic consulting and we work with clients to ensure the timely and concise exchange of information among all stakeholders.