Strategic Clinical Development Consulting Services
Our experienced team members provide a variety of consultative services, based on a unique sponsor communication/interaction model focusing on customized needs, ranging from ad hoc guidance to the design of a comprehensive strategic clinical development plan. In addition to providing medical and scientific input into clinical protocols a priori, we are well qualified to evaluate challenges with ongoing studies and to identify and implement solutions for effective protocol execution.
We want to be your trusted partner in the efficient clinical development of your product.
Our services include the following:
- Comprehensive Clinical Development Planning
- Cardiac Safety Consulting
- Clinical Pharmacology Consulting
- Protocol Design, Data Analysis, and Reporting
- First-in-human studies
- Single- and multiple-ascending dose studies
- Proof-of-concept studies
- Drug-drug interaction studies
- Food and gender effect studies
- Renal and hepatic impairment studies
- Studies in other special populations
- Pivotal registration trials
- Thorough QT studies
- Bioequivalence studies
- Post-approval commitment studies
- Clinical Trial MonitoringÂ
- Medical and Scientific Writing
- Abstracts
- Manuscripts
- Clinical protocols
- Clinical study reports
- Clinical development plans
- Sections of IND application
- Sections of NDA/CTD