Phase 1 Dermatology

Phase 1 Dermatology Clinical Trials

TKL has decades of experience in Phase 1 dermatological safety studies and dermatology clinical trials :

  • Human repeat insult patch tests (HRIPT)
  • Cumulative irritation (CUM)
  • Phototoxicity
  • Photosensitization
  • Maximal use
  • Pharmacokinetic studies
  • Proof-of-concept studies

TKL’s Phase 1 Unit, located in Paramus, NJ, is well equipped and well staffed to successfully conduct your Phase 1 trial needs. With senior staff exceeding 20 plus years, we believe there is no other clinical research organization in the world that has performed the number of ICH-dermatological safety studies as TKL Research.  TKL’s Phase 1 Unit provides:

  • Corps of certified clinical research coordinators
  • Highly trained staff:  RNs, phlebotomists, ECG techinicians
  • Superior recruitment with an active volunteer database of 20,000+
  • Temperature-and-humidity-controlled drug storage
  • Pharmacy-grade refrigerator and ultralow -86 degree Celcius freezers
  • Backup generator
  • On-site sample processing to be analysis ready for hematology, blood chemistry and bio-analysis
  • Local safety laboratory for 24/7 stat results
  • Biopharmaceutical lab on site
  • IV infusion capability, compounding of sterile materials

TKL offers a comprehensive set of services to assist in conducting your study:

  • Protocol development and consultation
  • IRB submission and approval
  • Recruitment management
  • Vendor management
  • Study conduct
  • On-site clinical data plan preparation, data management and biostatistics
  • Medical writing for protocols, CRFs and clinical study reports
  • Quality assurance for compliance and process

With a subject database of approximately 20,000 subjects consisting of healthy volunteers as well as subjects with specific dermatological disease states, we will deliver the full contingent of subjects to our sponsors within the specified timelines of the study.

Learn more about our:

Brochure

Download our Phase 1 Services Brochure.

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