Phase I Clinical Research is as Demanding as it is Dynamic

Phase I research involves constantly moving elements, including toxicology results, regulatory requirements, program optimization, study design strategy and drug readiness. Initial human data are a critical development milestone. Our multidisciplinary Phase I PRO team of top experts can work as an extension of your team, to provide tactical options tailored to your asset’s early development, guiding you to proof-of-concept swiftly, with a meaningful exit.

  • >800 Phase I professionals
  • 300 beds in North America
  • >150 beds (access to) in Asia Pacific
  • >150 Phase I clinical trials conducted annually
  • >25 years of reliable Phase I operations
  • 3 distinct regulatory environments
  • 0 483's issued in our clinics
They are very customer-focused. They become part of your team, which is great, and you can communicate with them at any time and have your request into the Project Manager or senior management and they take care of it right away. I would say they are very customer-focused.
- Mid-Sized Pharmaceutical Company Specializing in Pain Therapeutics

From Lab to Life

Whatever the size your organization, our Phase I PRO Team can bring your asset from lab to life. With units in Miami, and Quebec City, and our Asia Pacific Catalyst Model in Australia, New Zealand, South Korea, Japan and China, we navigate obstacles throughout your Phase I development.

Our combined facilities provide access to three different regulatory environments in four unique geographies, including hospital-based units in Australia, with their simplified regulatory study start-up process and biotech-friendly tax refunds, and in Japan for parallel access to the second largest pharmaceutical market.

 

The Art of the Start... and Finish - Full Service Phase I Solutions

From First In Human to Japanese Bridging, Alcohol Interaction to Abuse Liability, we can conduct any Phase I study. Our Center of Excellence model leverages complementary operational specialty areas to provide the best and most recent technical experience to ensure flawless planning and conduct.

Our leadership across units ensures quick escalation of issues, governance, and teamwork for rapid response and resolution. Top-quality bioanalytical laboratories in Princeton, N.J. and on-site at our Quebec City clinic ensure rapid turnaround of PK data for inter-cohort safety decisions.

 

Experienced Global Sites

  • Miami: In-Patient, FIH, Telemetry and Translational Medicine
  • Quebec: FIH, Biosimilar, QTc/Telemetry, Large Logistically-Complex and On-site Bioanalytical 
  • APAC: FIH, Biosimilars and Ethnic Bridging

 

Study Types Supported:

  • Alcohol Interaction
  • Bioavailability
  • Bioequivalence
  • Drug-drug Interaction
  • Dose Proportionality
  • Ethnic Bridging
  • Food Effect
  • First In Human and SAD-MAD
  • Hepatic Impairment Studies
  • In-Patient
  • Pharmacodynamic
  • Proof of Concept
  • Thorough QT or QT Precision Studies

 

Integrated Pharmacometrics Insights

Our established Pharmacometrics group has been building predictive mathematical models for over 10 years. Our in-silico or virtual patient models allow us to combine multiple sources of existing PK data and predict response.

We apply these throughout development to avoid missteps and gain greater insights:

  • Before Phase I to predict therapeutic dose/work backward to determine optimal dose in Phase I
  • Live on-study during safety meeting to guide intra-cohort decisions (adaptive design)
  • Prior to pharmacodynamics and confirmatory trials to predict PK/PD response relationship
  • Prior to confirmatory trials in a given population to predict PK/PD response relationship
  • To justify non-standard regulatory strategy 

 

Unique Win4 Phase I Patient Access Models 

Gaining patient insights earlier has become a strategic approach in Phase I. With no proven therapeutic benefit of a drug, and the exploratory and safety-focused nature of early research, the industry has been challenged to ethically motivate participation and engagement of patients and investigators while maintaining control and confinement period oversight.

Our Win4 Phase I Patient Access Solutions consists of three unique collaboration models that promote partnership with select investigators and their patients, while incorporating experienced staff and facilities for the conduct of study components.

Model 1: Partnership and Shared Tasks 
Certain components are conducted at the sub-investigator site, such as recruiting and screening, others at our Phase I unit using our staff with the sub-investigator present. This ensures access to medical history to improve enrollment and continuity of care 

Model 2: Divide and Conquer
 A portion of the study is conducted at our collaborator’s site and the balance at our Phase I unit in addition to any CRO services

Model 3: Out-Patient Study Network
Site feasibility, selection and management, and investigator support for study conduct and any peripheral CRO services

We call these Winmodels because they represent a winning solution for all four major stakeholders:

  1. Patient
  2. Investigator
  3. Sponsor
  4. CRO

 

Market Assessment, Forecast and Asset Valuation Right-Sized for Phase I

As the only healthcare organization to provide a fully integrated CRO-CCO model, we are committed to bringing commercial business strategy significantly earlier in development. Our Commercial Modules for Phase I development organizations include fixed-price Disease Area Opportunity Assessments, Forecast and Asset Valuation, Non-Proprietary Drug Naming, Clinical Trial Branding, and Pricing and Market Access Assessments.

We work with you to develop a targeted product profile and value proposition and test it, then generate a revenue forecast using our proprietary Forecast and Valuation Tool and Negotiation Trade-Off Matrix customized to your organization to perform a direct comparison of various milestone payments, royalty structures and deal terms.

We deliver insights into the valuation of your asset and provide guidance around optimal exit strategies, arming your C-suite with vital negotiating tools. After all, your success is our business.

 

Benefits to You:

  • Customized exploratory solutions designed to move your candidate drug swiftly to POC
  • In-silico predictive modeling, unique patient access solutions, commercial strategy and scientific leadership to help you gain the greatest insights and make the right decisions, sooner
  • A team with a passion to explore, flex, guide and deliver, who shares your dream
Perspectives: 
  • Oncology
  • Early Phase
05.27.19