WHITE STAR CONSULTING
Assisting organizations' transition from research through clinical development to commercialization with cost-effective solutions designed to accommodate the needs of early-stage development organizations.
OUR VALUE PROPOSITION
It can be challenging for companies and organizations who are moving from the research phase of product development to conducting regulated clinical studies, and hopefully to a transaction or commercialization of the product. Having the experience and knowledge base necessary to navigate this process can be difficult or costly to obtain, particularly for organizations where they have yet to access the capital markets. Most often, these organizations are at the mercy of the CRO industry.
White Star Consulting provides a cost-effective alternative, where the client can access consultants with extensive knowledge and experience without having to pay for the overhead and redundancies of a full service CRO.
Our value is that we provide purpose fit solutions for organizations at reasonable prices and deliver in the required timeframe. Experience and expertise are the intellectual property of a consultant. We know how to complete the tasks at hand and avoid pitfalls that can delay projects or drive up costs.
FLEXIBLE PURPOSE BASED SOLUTIONS
Translating research in the clinic for regulated products can be challenging. Whether building an organization and infrastructure to manage the proce3ss or outsourcing to a Contract Research Organization can be difficult and costly. Often all that is actually required is a few highly experienced consultants that have the know-how and capabilities to guide the process or perform the key functions without the burden of the overhead and costs of a CRO.
However, finding and contracting with a disparate set of consultants can be a time consuming process that may not yield a successful fit for the task or fit for the budget constraints of a star-up organization. Ideally, having a group of highly skilled consultants who are solely focused on all aspects of clinical development has not been available until now.
We provide a flexible engagement model that allows our clients to use our consultants ‘as required’. We can bring a team of experts who can be part of your team, or individuals to perform specific tasks for specific projects, or provide high level strategy, planning and guidance as a member of your management team. We have often taken direct roles in organizations where we manage a team to the completion of a defined goal, i.e., the launch of a clinical study.
FULL-TIME MANAGEMENT
We have often come into organizations in leadership positions to build out a clinical development team and department or manage a product through early to late-stage clinical studies. These are defined roles with specific goals and a projected timeline. At the successful completion of the goal, we transition out of the organization who are left with a team of employees prepared to lead clinical development for future products.
PART-TIME ROLES
During the clinical development process, an organization will need an individual with a specific set of skills or experience. Through White Star, we provide individuals who take on a role in the organization, frequently part time, to manage the process, such as building and managing an EDC solution and database that conforms to FDA guidelines.
PROJECT BASED TASKS
We have the flexibility and breadth of consultants that, when appropriate, we can bring in consultants who can manage and complete a specific project for a defined cost. Usually these are short term projects that are adjunctive to a larger development program, such as identifying and selecting a vendor.
