Delivering Value & Enabling Marketability
In the clinical trial industry, reputation, experience and expertise all count. Today, the clinical trial industry is adapting to a new reality caused by the economic impact of mergers and acquisitions, workforce reductions and changes in FDA guidances. Industry Sponsors (Pharma, Biotech and CROs) have been forced to reduce cost and increase their efficiencies to produce timely, quality trial outcome data. To do so, they are streamlining the process by which they select and contract with clinical trial sites. More and more often, they are seeking to accelerate their clinical trial process by relying on a network of certified providers.
As a result, clinical sites are working harder than ever to meet the changing needs and expectations of Sponsors who are increasing the amount and type of data to be derived from each clinical trial. These challenging demands are why it is critical that clinical trial facilities have the appropriate resources at hand to identify and maintain the right balance between capital expenses—including technology and equipment requirements—and personnel investment— including the type and appropriate levels of staffing expertise.
The customized services of the ClinPharm Network, Inc. are designed to allow clinical sites to identify their strengths, mitigate their weaknesses and exploit opportunities to be awarded the clinical projects that will ensure their business long-term success and prosperity. We deliver the type of foundational, operational, and strategic management expertise crucial to assist clinical trial facilities in meeting the ever-increasing demands of the CROs, Pharmaceutical and Biotech companies..
Among the services, ClinPharm Network, Inc. provides for clinical trial sites are:
- Comprehensive Facility Audits
- Organization Structure Design
- Management structure
- Departmental structure
- Staff mix
- Job descriptions
- Assessment of internal operational processes
- Assessment and development of Quality Control programs
- Assessment and development of Quality Assurance programs
- Tailored site specific Training Strategies
- Wide-ranging document preparation, management and review
- Customized and thorough assessment/review and development of Industry standard site specific SOPs
- Full service facility design and renovation support
“To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve—to be much more streamlined and efficient, and at the same time better equipped to answer the pressing questions that confront both patients and health care professionals.” Janet Woodcock M.D., Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA)