Study Start Up
Achieving site activation in the shortest timeframe possible is a key goal for Sponsor companies. We recognize this objective and have established a highly experienced team who can support the startup process, overseeing all the elements required to reach this major milestone. Our team works with study management and site personnel to prepare all necessary regulatory documentation for ethics submission, Site Governance packages, study budgets and contracts in an efficient and comprehensive manner. We ensure Sponsors remain informed on all activities in a clear and transparent way.
Our team will simultaneously manage all aspects of Study Start Up.
Regulatory Documentation preparation and submission
Achieving an efficient ethics committee approval is everyone’s goal, however not always realized. With experience comes knowledge on opportunities to devise optimal strategies and maximize efficiency. There may be alternate pathways to obtaining approval, so why not let us provide some options for consideration.
Budget Negotiations and Site Contracts
Developing and agreeing on a study budget and contracts can be a major time and resource consuming step. Exchanges between sites and Sponsors can be prolonged, particularly when time zones are different. We can work on Sponsor’s behalf to liaise directly with the site staff , gain agreement on budget and discuss any proposed contractual inclusions. Our unique knowledge and understanding of the local clinical environment enables us to efficiently achieve the goal which ensures all parties needs are met.
Prepare and maintain Trial Master Files
TMF’s are a critical compilation of documents that ensure the compliance of the study conduct in preparation for a possible regulatory inspection. Our staff have a vast experience with the processing of TMF documentation to ensure all the critical pieces are included specific for your clinical trial program and remain inspection ready. This compliance remains a core focus, not only during start up, but throughout the entire regulatory life-cycle.
Investigational Product Warehousing and Distribution
There are numerous warehouse and logistics vendors available who can manage the distribution of investigational product to study sites, however not all may be right for your study. Let us provide options of suitable vendors, and once a preferred vendor is nominated, we can manage the set up process with them to ensure an efficient product receipt and dispatch process.