For over 10 years KreaMedica has offered his partners a wide range of consulting services in project management, monitoring, and corporate development. Our contracting process is rapid, streamlined, and provides our partners with a “one-stop-shop” experience for outsourcing to a world-class CRO/CMO network.
Set Objectives and Expectations
We begin with the end in mind and work with our partners to define the objectives of - the goals will be different and so will be the solutions:
- Do you need to generate a data set to support a seed round?
- Are you looking for specialized CROs to confirm academic data?
- Do you need to conduct a non-clinical safety program in a cost- and time-efficient manner?
- Are you exploring reformulations or new indications?
With the scope in mind, we form the core development team with our partner and generate a development plan. KreaMedica works with independent industry veterans to fill knowledge gaps and reflects the intrinsic properties of the drug candidate and its treatment modality, the regulatory environment, and clinical plans. (Link to Expert Network).
First, we identify appropriate vendors which meet the requirements of the program. We focus on a fit-for-purpose approach to ensure that time, efforts, and money are spent appropriately. We constantly extend our network of potential vendors and they can submit their profile here: link coming soon...
When a company decides to use outside vendors, implementing expert vendor management is critical. Our project managers are well versed in vendor management throughout the duration of the studies. We provide our partners with a customized and comprehensive support, as we are also able to leverage KreaMedica’s broad array of services to meet your specific and unique needs.
Scientific Program Management
Our project managers and external consultants are experienced scientists skilled at managing all technical and operational aspects of non-clinical and clinical activities that have been outsourced to CROs or specialized laboratories for bioanalytical, immunological, or pharmacology studies.
Our procurement team works with the vendors to ensure that their bids reflect the RFQ provided and delivers a comprehensive overview to our partners. For GxP-compliant work, all vendors are qualified to ensure that they meet regulatory compliance.
Our study monitors work with the broader toxicologist and have many years of expertise gained from running and monitoring GLP-compliant pre-clinical toxicology studies, at a wide range of CROs. This requires highly developed communication skills to allow open and effective dialogue between the Sponsor and CRO.
On-site the monitors follow the drug from storage, formulation, administration to blood draw and processing and finally necropsy.
"If you can't explain it simply, you don't understand it well enough."