TKL Research is one of the oldest, independent clinical research firms in the United States. We manage multi-center trials through our Clinical Trials Division; conduct studies in our solely owned and operated clinical centers through our Clinical Studies Division; and provide recruitment management services through our Recruitment Management Division, Predictive Enrollment Partners. Marked by steady growth for over 60 years, TKL has developed a reputation for high quality, cost-effective delivery of clinical research.

Multi-Center Trial Services
Our Clinical Trials Division provides comprehensive services for designing, managing, monitoring and reporting on large multi-center studies. We conduct clinical studies in a variety of therapeutic specialties, primarily focusing on Phase II – IV clinical trials and Rx-to-OTC switches.

Clinical Site Services
Our Clinical Studies Division conducts pharmaceutical and consumer product clinical studies at TKL’s four research centers in the New York metropolitan area. Capabilities include safety, efficacy and claim substantiation trials.

Patient Recruitment Services
Our patient recruitment division, Predictable Enrollment Partners, develops centralized recruitment plans for studies, designs creative and effective advertising programs, customizes the strategy for each site and manages the patient flow from screening through completion for the duration of the study.

Our Clinical Trials Management Division provides comprehensive services for designing, managing, monitoring and reporting on large-scale studies conducted at multiple, non-TKL sites around the country. Our services include:

Strategic Planning

• Clinical Plan Development
• Regulatory Consultation
• Regulatory Authority Procedure/Process
• Submission Strategy
• Issues Management
• Information Searches
• Budget Development

Recruitment Management

• Site-By-Site Recruitment Support Programs
• Development of Customized Recruitment Plans
• Centralized Resource for Patient Recruitment
  • Professional Advertising Materials
  • Effective Media Placement
  • Customized Telephone Screening
  • Documents for Each Study Site
• IVR Capabilities
• Full-Service Call Center Operations

Trial Management

• Single and Multicenter Trials
• Investigator Selection
  • Database of Experienced Investigators
  • Wide Geographic Distribution
• Grant Submission
• Coordination of Study Drug Packaging and Distribution
• IRB Submissions
• Regulatory Document Processing
• Selection and Coordination of Central Laboratory
• Multicenter Meeting Coordination
• Central and Regional Clinical Monitoring
• 100% Source Document Review and Data Verification
• Quality Control Review
• Customized Reports
  • Project Tracking Reports
  • Monitor Reports
  • Patient Data Flow Sheets
  • Demographic Listings
  • Adverse Event Reports
  • Investigator Newsletter

Monitoring Services

• CRAs are required to have two or more years of field monitoring experience
• CRAs have full knowledge of all regulatory guidelines: CFR, FDA, ICH
• Complete project activities associated with Phase I - IV clinical research trials
• Pre-study site evaluations and recruiting investigators
• Collecting investigator documentation
• Preparing/reviewing protocols
• Participating in investigator meetings
• Site initiation, monitoring, closeout and training
• 100% source document review and data verification

Data Management

• Custom Database Development
• Project Tracking and Reporting
• Validation of Data
• Verified Data Entry
• Preferred Term Coding
• Custom Database Edits
• Documented Audit Trail
• Compatible Data Transfer

Biostatistics

• Protocol Development and Review
  • Study Design and Sample Size Estimation
  • Randomization Procedures
• Statistical Analysis
• SAS Programming
  • Client Customized SAS Datasets
  • Data Listings/Tables
  • Graphical Data Presentation
• Consultation

Medical and Regulatory Communications

• Investigators’ Brochures
• Protocols
• CRF Design and Production
• INDs
• Integrated Clinical and Statistical Reports
• NDA Summary Sections
• Paper NDAs
• FDA Rebuttals
• Manuscripts for Publication
• Backgrounders
• Product Monographs
• Posters

Quality Assurance

• Quality Control Review
  • Case Report Forms
  • Regulatory Compliance
  • Audit Trail Components
• Clinical Monitor and Auditor Training
• Quality Assurance Audits (GCP, GLP)
• Investigator Site Audits for Conformance with SOPs/Regulations

The experience and depth of knowledge of the TKL management and staff is the single most important reason why TKL is recognized as a research organization whose expertise complements your own. Senior level professionals manage every project, large or small, to ensure that quality is built inform the beginning. Our management includes:

• Jon C. Anderson, PhD - President, CEO
• Robert C. Reardon, PhD – Executive Vice President, COO
• Jonathan Dosik, MD – Medical Director
• Michael Anderson – Senior Director, Project Management (Clinical Trials Division)
• Richard Gilbert, PhD – Senior Director, Biostatistics, Data Management, Medical Writing
• Darcee Duke Strube – Senior Director, Clinical Development Services (Clinical Trials Division)
• Greg R. Anderson – Director, Clinical Development Services (Clinical Site Division)
• James Biribaur – Director, Clinical Data Management (Clinical Trials Division)
• Charlene Constantinou – Director, Corporate Quality Assurance
• Milena Reckseit – Director, Recruitment Management
• Joy Taurozzi, RN – Director, Business Development Services (Clinical Site Division)
• Oiman Cheung – Assistant Director, Information Technology
• Deborah Thompson – Assistant Director, Clinical Monitoring (Clinical Trials Division)
• Maureen Damstra – Manager, Clinical and Photobiology Studies (Clinical Site Division)
• Kathleen Georgian – Manager, Dermatologic Safety (Clinical Site Division)
• Sarang Rastogi, PharmD – Manager, Clinical Development Services (Clinical Trials Division)

TKL also conducts clinical studies in our own clinical centers. For more information about our Clinical Studies Division, Click here.

For more information about TKL's recruitment management division, Predictive Enrollment Partners, Click here.

Contact Information

TKL Research, Inc.

365 W. Passaic St.
Rochelle Park, NJ 07662 USA
Phone: 201-587-0500
Fax: 201-587-0209
E-mail:

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