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THERAPEUTIC EXPERTISE

Early Phase Studies

At Linical, we offer comprehensive early phase clinical trial management services providing support in the design, conduct and interpretation of study results.

Our experienced team combines medical expertise with operational efficiency to assist clients in the development of all elements of their early phase program, from study design and participant selection to outcome assessment and long-term follow-up.
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PHASES

Early Phase Clinical Trial Design and Management

Early phase clinical trials aim to assess the safety and tolerability of a new treatment in humans, providing essential information on its profile and potential therapeutic benefit. Linical works with a meticulous and systematic approach, overseeing the project from start to finish, enabling efficient management of time and resources while ensuring the safety of participants and compliance with regulatory and ethical standards.

Comprehensive CRO Services for Phase I Clinical Trials

Linical is present in more than 40 countries and has a network of partnerships with the best-in-class analytical laboratories and Phase I units in main destinations for clinical trials, which allows us to offer our clients a full range of services for early phase clinical development including:

  • First-in-human studies
  • Proof-of-concept studies
  • Micro-dosing studies
  • Single Ascending Dose/Multiple Ascending Dose studies
  • Biosimilarity/Bioequivalence studies

Early Phase CRO Expertise

Linical offers a range of Phase I clinical research capabilities to support your early development program. From early phase clinical trial design, to regulatory support and data management, our solutions are designed to get you the key data you need, in a rapid and cost effective manner. Our early phase CRO services include:

Regulatory Affairs

Regulatory Affairs

  • Pre-IND/IND Services
  • Ethics Review Board Submission

Medical Affairs

Medical Affairs

  • Informed Consent Documents
  • Medical Writing
  • Medical Monitoring
  • Pharmacovigilance

Clinical Trial Planning and Study Conduct

Clinical Trial Planning and Study Conduct

  • Regulatory Approach
  • Protocol Design
  • Program Development
  • Phase 1 Site Selection

Study Conduct and Project Management

Study Conduct and Project Management

  • Recruitment of Healthy and Patient Populations
  • Clinical Trial Monitoring
  • Study Execution
  • Timeline and Budget Management
  • Project Communication Planning

Data Management and Biostatistics

Data Management and Biostatistics

  • Experienced Early Phase Project Teams
  • High-Quality Clinical Study Reports

Explore Linical’s Early Phase CRO Services

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Drug Development Strategy

Drug Development Strategy

Linical provides comprehensive solutions for drug development strategy, including regulatory affairs, protocol development and study design, medical writing, and quality assurance.Through assessing scientific, regulatory, and commercial considerations, Linical works in collaboration with clients to optimize your trial’s drug development strategy.
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Clinical Trial Management

Clinical Trial Management

Linical’s comprehensive clinical trial management services are designed to help your program achieve high-quality data, on time and on budget. From study start up and feasibility, to project management, biometrics, and drug safety, Linical has the flexibility and experience you need.
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