Clinical Trial Management

Starting with first-in-human, PK and Phase I studies, advancing through comprehensive, multi-center Phase II - III trials, and continuing with evolving post-marketing Phase IV studies, TKL is your premier and seasoned CRO of choice.

Study Start Up

  • Protocol & ICF Writing/Review
  • Site Feasibility, Selection, Training
  • IRB/Ethics Committee Submissions
  • Study Plans
  • Kickoff/Investigator Meetings

Project Management

  • Team Communication
  • CTMS/TMF Setup & Mgmt
  • Vendor Mgmt
  • Study Tracking;
    Enrollment, Budgets & Timelines
  • Site Budgets, Contracts, Payments

Data Management/ Biostatistics

  • EDC Build & Management
  • Data Management &
    Statistical Analysis Plans
  • Query Management
  • Data Review/Identify Trends
  • Full Analysis, Generate TLFs

Study Management

  • CRF Creation
  • Randomization
  • Interim Analysis
  • Data Management

Flexible. Quality-Driven. Sponsor-Focused.

We are the solution that you have been seeking…

Early Development

Due to the importance of early phase clinical research, we made the decision to build our own 50 bed clinical pharmacology unit adjacent to our headquarters in Fair Lawn, NJ. Navigating the intricacies of a phase I clinical trial requires a high level of expertise, clear communication and agility in order to hit key data milestones without delay. At TKL, we believe daily oversight by our team provides us with the power to move you swiftly through to proof of concept – building a foundation for later-stage success.

The experience gained by running hundreds of early development studies overseen by our own team is unprecedented. We have spent years building an infrastructure utilizing the latest technology to create customized a streamlined approach as well as offering a diverse patient/healthy volunteer at our fingertips in the heart of the NYC metro area.

We are not your average CRO.

Phase II-IV

Over the course of our 80+ years in this industry, we have built an infrastructure to fully support your late phase studies from start to finish.  We offer the full suite of CRO services, possess the technology and the depth of experience to provide our sponsors with the most efficient, streamlined approach possible. With the ever changing variables in clinical research, we are always prepared for any setbacks that may occur.

Stand-Alone Services

Not looking for the full suite of CRO services, no problem.
We offer many services on an as needed basis including:

  • Medical Writing
  • Protocol Development
  • Biostatistics
  • Data Management
  • Pharmacovigilance