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.

Predictive Enrollment Partners is the Recruitment Management division of TKL Research, Inc., a 60-year old firm offering both clinical site and CRO services. We recognize that an expertise in marketing and advertising is fundamental to this specialized service industry; our experience in this area is solid.

But, what makes Predictive Enrollment Partners different from any other recruitment management service is the strength of our experience, which is first and foremost, clinically-grounded:

Features	Benefits
PEP is an outgrowth of our clinical site recruitment experience Offers an expertise in marketing, advertising and media planning/placement	The entire process – analytic projections, marketing and advertising strategies and media programs are clinically grounded in our experience as a site…the cornerstone to a complex process Over five decades of clinical site experience to draw from Recruitment and clinical staffs work in tandem

As a result of our difference in the marketplace, Predictive Enrollment Partners’ recruitment management plans:

• are directly and solidly linked to study criteria
• are based on experience of recruiting into our own TKL sites
• cater to specific, identified target audiences
• are closely tracked using meaningful performance standards

We know that there is an absolute cornerstone to successful patient enrollment: a sound predictive recruitment process. This complex process - analytical projections, strategic planning and media vigilance, synergistic creative tools, layered screening, interactive site management and continual assessment and financial control - which are all clinically-grounded - all contribute toward predictable patient enrollment.

Process	How We Do It/What’s Different	Benefits
Analytic Projections	critically examine protocol for crucial elements and analyze impact translate criteria into recruitment projections establish meaningful performance standards identify subsets of target audience balance demographics with media usage habits	Sets the objective and metrics for developing a RMP which is solidly linked to study criteria and specific target audiences
Strategic Planning and Media Vigilance	identify how to reach target subject define media strategies for individual markets use proven “direct response” techniques negotiate media in every single market analyze performance on a DAILY basis quickly interpret, and redirect media resources in response to performance metrics	Strategic, efficient media planning and intense tracking alerts to changes; can make real-time, impactful, cost-saving decisions
Synergistic Creative Tools	capture profile of target subject develop look/feel of advertising extract essence of recruitment message develop study identification and branding tools	The synergy created by a singular, cohesive message makes advertising more effective and believable; media buy is more efficient; heightens awareness
Layered Screening	3 Layers well-designed, study specific phone screener recruiter training subject follow-up	Well-screened, committed subjects ensure high likelihood of enrollment; builds commitment, enthusiasm, compliance
Interactive Site Management	Process gaining confidence, eliciting cooperation, securing commitment Effective partnering frequent contact, listening, interview, interpretation, taking action	Team approach – No substitute for the decision-making information gained by establishing trusting, working relationships with site personnel
Continual Assessment and Financial Control	establish important, productive relationships with PMs and SCs maintain performance trackers and cost control measures	On-going, daily review of productivity allows for anticipation of change and at what cost

Without clinical-grounding, there is no basis for predictable enrollment. We have over five decades of clinical trial experience, and we know what it really takes to recruit and enroll studies. The broad therapeutic areas we span include: Rx Phase II - IV, OTC drug, and Rx-to-OTC switches. Our focus is in pain management, women’s and men’s health, dermatology, gastroenterology and several other areas defined by ambulatory, outpatient populations

Products and Services

• Strategic Planning
• Budgeting
• Creative Development
  • Advertising materials
  • Direct mail materials
  • Study name/logo design
  • Collateral materials
• Study Identification
  • Category information searches
  • Branding development
  • Trademark searches/trademarking
• Media Development
  • Planning, negotiating, purchasing
• Website
  • Design and development for Recruitment/Milestone Recognition Programs
  • Programming
  • Hosting
• Call Center
  • Inbound/outbound capability
  • Fully computerized
  • Operational 7 days a week
• Screening and Follow-up
  • Protocol-specific screeners
  • Fully trained recruitment staff
  • Mini Callback program
  • Welcome letters
  • FAQs/Backgrounders
• IRB
  • Central IRB submissions and approvals
  • Local IRB prep packets
• Milestone Recognition Programs
  • Budget development
  • Resourcing and negotiation
  • Imprinting
  • Storage and shipping
  • Site and direct-to-subject programs
• Investigators’ Meeting
  • Information kits
  • Recruitment/Milestone Recognition Program seminars

The benefits of Predictive Enrollment Partners’ Recruitment Management Program:

• it is a purposeful positioning which complements each site’s recruitment/enrollment efforts; we gain the sites’ understanding of how we can help and assure that they are geared for the momentum;
• it is a process which allows us to respond very quickly to individual site’s needs
• it is a process which allows us to anticipate when change is necessary and to make adjustments rapidly
• it is a process which typically shortens enrollment timelines

Our location:

365 W. Passaic St.
Rochelle Park, NJ 07662
Phone: 201-587-0500
Fax: 201-587-0099
www.pep.tklresearch.com

Following are the therapeutic area/indications that Predictive Enrollment Partners has worked on with numerous clients:

Broad:

• Rx Phase II - IV
• OTC Drug
• Rx-to-OTC Switches

Focus:

• Pain Management
• Women’s Health Issues
• Men’s Health Issues
• Dermatology
• Gastroenterology
• Other areas defined by ambulatory, outpatient populations

Contact Information

Predictive Enrollment Partners
Milena Reckseit, Managing Director
365 W. Passaic St.
Rochelle Park, NJ 07662 USA
Phone: 201-587-0500
Fax: 201-587-0209
E-mail:

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