Clinical Trial Management Services

Maitland’s affiliated company, IMMUNOCLIN, is a clinical trial management company with Central Labs in London- UK and offices in Ireland. Since 2000, Immunoclin has been providing clinical trial support for both the pharma and nutraceutical industries, as well as UK-independent services to the EU. Since 2000, our clinical team has managed hundreds of clinical trials.

Our “one stop shop” capability allows to us to do the following:

  • Create a development strategy
  • Manufacture clinical trial materials
  • Develop clinical trial protocols
  • Locate suitable clinical trial sites
  • Prepare and submit the clinical trial application (CTA/IND)
  • Manage the clinical study
  • Analyze the resulting data and submit these reports to the applicable regulatory agencies.

Some specific areas of expertise include:

  • Design, execution and monitoring of clinical development programs (GCP) and clinical studies for Phase I, II, III and IV
  • Preclinical and clinical trial management for both USA and Europe
  • Regulatory consulting, including applications to IRB/ethical committees, IND applications in North America (FDA and Health Canada), Latin America, Europe (EMEA and national regulatory bodies)
  • Legal representation for non-European Sponsors of clinical studies within European Economic Area countries as per EU directive 2001/20/EC

Other services

  • Development of cannabinoid therapeutics and assistance with regulatory compliance
  • Assistance sourcing hemp extracts and cannabinoids for clinical, veterinary, and cosmetic applications