Early Phase

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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.

  • >500 Phase I professionals
  • 376 beds in North America
  • >150 beds (access to) in Asia Pacific
  • >150 Phase I clinical trials conducted annually
  • >23 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, Toronto 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

  • Toronto: CNS, Abuse Liability, FIH, and QTc/Telemetry
  • 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:

  • Abuse Liability
  • Abuse Withdrawal
  • Abuse Deterrent
  • Alcohol Interaction
  • Bioavailability
  • Bioequivalence
  • Drug-drug Interaction
  • Dose Proportionality
  • Ethnic Bridging
  • Food Effect
  • First In Human and SAD-MAD
  • In-Patient
  • Pharmacodynamic
  • Proof of Concept
  • QTC
  • Respiratory Depression

 

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

 

Center of Excellence for Human and Abuse Dependence Potential (Liability) Studies

Abuse and dependence potential evaluations are integral in the development of CNS active medications that guide drug scheduling. Abuse potential studies serve as important proofs of concept, evaluating the effectiveness of abuse deterrent formulations and enabling strategic labeling claims.

Design and execution are critical to success. Considered as key opinion leaders by regulatory authorities, our Toronto team was the first CRO to conduct abuse potential studies under Good Clinical Practices and we have conducted more than any other CRO.

We are the first and only CRO conducting physical dependency studies, and have been instrumental in evolving clinical trial methods. Our key opinion leaders have led many forums with regulatory agencies to provide input on guidance on abuse potential evaluation by both the FDA and Health Canada.

Our team regularly interfaces with regulatory bodies, including the FDA, Controlled Substances Staff, and Health Canada to ensure timely regulatory advice in guiding scientifically robust experimental design.

Situated in the fourth largest city in North America and accessible by public transit, our Toronto unit and CNS Center of Excellence contains a database of over 13,000 recreational drug users.

The searchable database contains subjects with a broad array of recreational drug use history and experience with various routes of administration. Through its wide array of pharmacodynamics assessments, our proprietary 21 CFR Part 11 compliant and validated electronic data capture system, PsychometRx™, enables reliable assessment and evaluation of the pharmacology of your investigational drug.

Highly experienced clinical neuropsychologists ensure subjects are carefully trained on assessments to ensure comprehension and reliable responding. Our passion for safety and intervention of societal crises has driven our leadership in this field.

Our commitment to evolving the methods for optimal testing ensures your study will be designed with utmost rigor from a regulatory, scientific, safety and operational perspective.

 

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