Are You Preparing For First-In-Human Clinical Trials?

With over 30 years of experience and 400 FIH studies completed, we are uniquely positioned to help you achieve critical milestones quickly and reliably. Each year, 50% of our clinical studies are FIH trials.

From protocol design to study start-up and conduct, we translate your nonclinical findings into clear FIH study designs and objectives, ensuring the best chance of finding reliable safety and proof-of-concept data to accelerate your drug development journey.

Need to Conduct a FIH Trial? Here's Why You Should Conduct it With Altasciences

With a focus on early-phase drug development, and a proven track record of conducting hundreds of FIH trials, we excel at guiding sponsors through this pivotal stage of development.

• Two Regulatory Pathways—Investigational New Drug (IND) for the U.S.A. and Clinical Trial Application (CTA) for Canada.
• Rapid Study Start-Up enables speedy mobilization to meet your needs. When timelines are critical, we can fast-track start-up to initiate your trials in as little as four weeks.
• Co-Located Clinics and Laboratories provide real-time data access to support faster decisions and adaptive study designs.
• Advanced Data Visualization deliver interactive safety reviews and real-time insights for informed, data-driven decisions.
• A Turnkey solution for First-in-Human Trials to tackle every aspect of your trial from start to finish.

Partner with Altasciences to confidently take your molecule from discovery to first-in-human and beyond. Contact us today to discuss your FIH study requirements!

Two Regulatory Pathways

We specialize in keeping your study on schedule from initiation to completion. With almost 600 beds in three inpatient clinical pharmacology units and a network of several hundred patient sites across North America, we offer dual regulatory pathways—Investigational New Drug (IND) or Clinical Trial Application (CTA).

U.S. IND Pathway

We provide full support, from pre-IND meetings to IND assembly, submission, and maintenance.

CTA Pathway

We handle everything from initial applications to ongoing compliance.

Rapid Study Start-Up

We excel at mobilizing quickly, accelerating start-up timelines to meet your needs. When timelines are critical, we can fast-track start-up and have initiated trials in as little as four weeks. Our teams define key planning elements early to ensure rapid completion of reviews and secure necessary clearances from regulatory authorities, ensuring your clinical activities begin on time.

Co-Located Laboratories

Our co-located bioanalytical laboratories provide real-time data access, enabling rapid decision-making, timely analysis, and quick PK data turnaround to support informed dosing decisions, ensuring your study remains both safe and effective.

Combining trial conduct and bioanalysis with Altasciences delivers significant benefits:

• Timed interim sample analysis for dose escalation decisions
• Rapid turnaround of PK/PD analysis between cohorts
• Biomarker assay development and validation for exploratory or primary endpoints
• On-site flow cytometry
• Centralized scheduling between clinic and lab
• Single point of contact with a dedicated program manager for streamlined communication

Accelerated Phase I Clinical Trials With Adaptive Protocols and Real-Time Data

Altasciences’ specialized early-phase clinical trial services include adaptive cohort management and real-time contingency planning, allowing for responsive adjustments based on emerging safety data for efficient milestone achievement. With our proprietary scheduling system, Compass, we can provide real-time insights into key performance indicators, financials, project scope, milestones, deliverables, and quality control.

Our team works closely with you to keep each stage on track, ensuring a smooth startup and adherence to timelines.

How Adaptive Trial Designs Can Accelerate Early-Phase Drug Development

Our adaptive clinical trial designs and umbrella protocols enable optimized data collection to ensure maximum valuable information from a single clinical trial, and seamless progress in complex SAD/MAD studies. This allows for real-time adjustments based on data analysis, optimizing information for precise dose escalation, safety monitoring, and successful NDA submissions.

Adaptive, integrated designs enable multiple early-phase assessments to evaluate compound safety (imbedded cardiac safety, biomarker and AE management), absorption (pharmacokinetics [PK], food effect, ethnobridging, formulation bridging), interaction (DDI; drug-drug interaction), and early efficacy (biomarkers, patient arms).

A Turnkey First-in-Human Clinical Trial Solution

At Altasciences, our primary focus is on early-phase drug development, so your FIH trial will never compete for resources with larger, later-phase trials. We drive your molecules to clinical proof of concept, delivering end-to-end preclinical, clinical, bioanalytical, and manufacturing solutions to give your program the momentum it needs.

A one-stop solution, our early-phase services encompass everything from clinical trial design and protocol development to patient recruitment, data management, biostatistics, trial conduct, bioanalysis, and regulatory guidance.

Ready to start your first-in-human study? Get in touch with us today!