Clinical drug development

We have expertise in the full range of drug development from pre-IND through NDA submissions and post registration trials (phase I through IV), in the US, Europe, and Japan.  We can assist clients in assessing the specific development needs of a product, including regulatory strategies or strategic commercialization.  We can also help plan and manage the full development program.

OUR CLINICAL DRUG DEVELOPMENT SERVICES INCLUDE:

• Strategic planning
• Clinical Development Plans
• Product Development Plans
• In-license evaluation
• Thought leader relations
• Phase I through IV study coordination
• Protocol writing and CRF design
• Investigator search and screening
• CRO selection and management
• Clinical and scientific report writing

Research & evaluation

We provide technical support in program planning and development, evaluation services, and capacity building to small and large projects in health care, public health, and educational programs on an international, national, regional and local level.  We have the knowledge and experience to plan, design and conduct context relevant program development and evaluation.  

OUR PROGRAM EVALUATION SERVICES INCLUDE:

•  Needs Assessment
•  Monitoring and Surveillance Systems
• Observational Research
• Program Design and Development
• Intervention Research
• Community-Based Participatory Research
• Evaluation Plans

We offer training and capacity building in program development and evaluation for nonprofit organizations.