Clinical Research Administration
Obesity PPM's service offerings in the area of Research Administration range from performing discreet retrospective analyses to functioning as a full-scale CRO (Contract, or Clinical, Research Organization) on studies related to obesity. Under the leadership of Dr. Margaret Yufera-Leitch, Director of Research, our work in biostatistics, study data management, and medical writing are best in class. We are comfortable working with your organization through the entirety of the study, or picking up at any point in the process -- we're here to help you achieve your objectives efficiently and cost-effectively.
Our Research Administration clients benefit from the use of Obesity PPM's web-based, secure portal for rapid communications and highly efficient study management. Customized for each study, the portal features project team communications, document and data repositories, project status reports, deliverables, and administrative information.
Our platform alleviates issues arising from stakeholders working in disparate geographies and time zones, and enables direct collaboration on deliverables in real time using familiar tools. By leveraging this mature technology platform, Obesity PPM is able to keep site visits, and therefore our client's costs, to an appropriate minimum, as well as ensure quality assurance of clinical data and reduce the overhead associated with consistent IRB (Institutional Review Board) reporting.
In the study Design, Planning and Initiation phase, Obesity PPM works with your organization in either a fully outsourced or a supporting capacity on:
- Study and/or experimental design;
- Protocol development;
- Project planning and costing;
- Financial modeling, grant writing, and project-specific fund raising;
- Site screening and selection, patient screening, and subject enrollment.
In the study Execution, Monitoring & Management phase, Obesity PPM supports your organization by:
- Offloading the administrative and management overhead associated with protocol adherence, data collection, data entry, and clinical data management;
- Managing safety processes, including AE (Adverse Event) and SAE (Serious Adverse Event) tracking, IRB communication, and documentation;
- Providing monthly analysis on key clinical data elements and project metrics;
- Managing communication between all stakeholders, providing contingency planning, and facilitating rapid problem solving.
In the Data Analysis, Medical Writing & Closing phase, Obesity PPM supports your organization by providing the following services, scaled to your study based on analysis volume and statistical modeling complexity:
- Biostatistical analysis, clinical data management with S-Plus / SAS® database formats;
- Creation of tables, listings and figures;
- Complete medical writing services;
- Creation of the final Integrated Clinical and Statistical Report, including patient and safety narratives.
To learn more about our Research Administration services, please call (877) 334-7970 or email This email address is being protected from spambots. You need JavaScript enabled to view it. .
