Strategic Consulting Services

Guiding you through the process

The cornerstone of PharPoint Research is our clinical trial consultants’ expertise, which is based on their involvement in multiple successful development programs. By listening and understanding our sponsors’ 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 sponsors 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.

PharPoint clinical trial 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 do so.

Services
Overview
Clinical Operations and Project Management
Data Management
Biostatistics
Strategic Consulting

Clinical Development Planning

Our 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 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.

CRO Oversight and Trial Support

Is 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.

Global Operational Strategies

Upon 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.

Safety Assessment

PharPoint 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 sponsors to ensure the timely and concise exchange of information among all stakeholders.

Regulatory Submission Support

We provide our sponsors 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 (DMC) organization, meeting administration, and charter preparation.

“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 sponsor's clinical research.”
– Dr. Jennifer A. Elder, PharPoint Research Chief Scientific Officer

Moya Hawkins, Senior Director of Consulting Operations

Ms. Hawkins has been in the CRO industry since 1995 managing Phase 1-4 clinical trials across both EDC and paper platforms, including global, multilingual Phase 3-4 studies.

Her database experience includes serving on EDC steering committees within several companies, application validation and serving as a point person for the implementation of the transition from paper based studies to EDC studies several companies. She was an integral part of the Medrio implementation team at PharPoint Research and serves as a platform expert within the company. Ms. Hawkins’ extensive experience includes managing a multi-country, emergency use protocol, studies with special patient populations, and salvage therapy studies. Ms. Hawkins also serves on a committee and volunteers for the Society of Clinical Data Management which is a is a non-profit, international organization founded to advance the discipline of clinical data management.