We support our clients in determining what is the optimal solution for their project from an unbiased perspective. Creativity and out of the box solutions are a must in todays market and should not be bound by internal restraints. We also help your drug development program to meet the current regulatory standards and to align with the direction of the Regulatory Agencies. We will cover nonclinical, CMC and the clinical requirements for your program and include the detailed costs and estimated timelines for you.
To consult in your drug development plan, our team is able to:
Aligning the Clinical Development Program: by reviewing the existing and upcoming clinical studies to ensure that the proposed strategy is in line with previously completed studies;
Supporting to Setting up a Development Plan: by reviewing the study synopses detailing the design and rationale of each study in the development plan;
Provide Risk Assessments and Mitigations: by identifying potential risks in the overall development plan as well as strategies for their mitigation;
Managing the CMC Program: by selecting the right partner and and overseeing the CMC program;
Project Plan Documentation: by providing a project plan documenting the schedule of the proposed studies and their inter-relationships with one another;
Manage Timelines and Budgets: by proving estimated timelines and overall cost projections.
Furthermore, we can provide a range of interim or part-time management support at executives or senior management level to fit your requirements.
Our consultants are experienced in building and reorganizing departmental structures and teams. Admin support is also another key aspect of our offering and can supply this in the form of support for finance, accounting and human resources. If a report for presentation is required for the board or to help raise investments, look no further. We regularly serve as part-time C-level executives for the periods where our clients do not yet need a full-time individual, due to resource capacity or financial restraints. By providing the possibility to use part-time resources, our clients gain access to high-level individuals with great networks at a cost they can afford. Our clients can then focus on the core activities of the business.
Besides individuals, we can work as project teams, utilising the experience in the functions of Clinical Operations, Medical Expertise, Business Development, Finance, HR, and Legal, to provide a unique combination of knowledge to design, and implement novel solutions that are tailor-made for the customer.