Company:

Surface Logix Inc

Summary

Niche is involved in EU regulatory strategy and clinical implementation, including:

Managing clinical trial application to EU/UK agencies
Legal representation
Clinical trial monitoring and local project management
Delivery of regulatory submission documents
- Investigational Medicinal Product Dossiers/INDs
- Investigator’s Brochures
- Clinical Protocols and trial documents
- Clinical study reports (CSR)
Uploading study findings to the EU clinical database

What our client said

"During my 5 years with Surface Logix Inc., a 25-person US biotech company, we have relied on Niche Science & Technology Ltd. for regulatory, clinical ops and medical writing functions."

John Ferkany, VP, Development

Surface Logix

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Project background

Surface Logix is a clinically active biotechnology company focused on novel drug delivery technologies and surface engineering for pharmaceutical and biomedical applications. The company has developed a broad range of clinical-stage, cutting-edge assets aimed at improving the effectiveness, safety and patient compliance of drugs by enhancing how they interact with biological systems. The focus is on improving the bioavailability of drugs and creating more efficient delivery systems and using them to address exposure and efficacy challenges.

Delivery

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.