Clinical Trials

LSL provides advice and counseling on federal and state laws governing the conduct of clinical research. LSL has experience with clinical trials contracting in over 40 countries.

Several clients have outsourced their clinical trials contracting functions to LSL, including Bayer HealthCare LLC, Talecris Biotherapeutics, Inc., and Schwarz Biosciences. We have also represented Gilead, Nobex, BioStratum, Asklepios BioPharmaceutical, and many other pharmaceuticals and biotechs with their global clinical trials needs. LSL has also worked with Site Management Organizations, such as Translational Genomics Institute.

We have developed and negotiated Contract Research Organization Agreements, Site Agreements, Data Transfer Agreements, Laboratory Services Agreements and Investigator Led Agreements among others.

In conjunction with the North Carolina Biotech Center, LSL conducts semi-annual symposiums addressing emerging issues in clinical trials. Some of the past topics addressed by the symposium include the European directive (presented in conjunction with Chiltern), contracting with academic institutions (presented in conjunction with Duke University and UNC-Chapel Hill) and conducting clinical trials in Canada (presented in conjunction with the Canadian Consulate and Genome Canada).

Finally, LSL attorneys are knowledgeable about HIPAA, the EU Directive, Stark Anti-kickback provisions, Part 11, and other regulatory requirements impacting clinical trials contracting. We are also able to provide our clients with advice on their recruitment practices and informed consents.