Niche began discussing Surface Logix’s clinical ambitions in 2001 as its first asset entered clinical development. Niche was invited to guide the small US biotech team on regulatory strategy and clinical implementation in the EU. Niche began to provide support for the development of all regulatory documentation. The Niche team’s expertise in the preparation of IMPDs, IBs, protocols and assembling and filing of clinical trial applications meant that it quickly and efficiently developed the necessary regulatory submission documentation. In a crucial 24-month period the partnership between the Niche and Surface Logix teams saw delivery of a series of clinical projects for three assets in rapid succession. As the clinical requirements increased, the Surface Logix team relied on Niche to provide a more executive function as part of their role as Legal Representative in addition to providing on the ground project management and monitoring for four clinical trials, for a range of indications. Niche became a crucial component in the clinical trial team.