The FDA requires that all new drugs be evaluated for adverse effects on the central nervous system during first-in-human (FIH) studies. If adverse effects are observed, such as somnolence, further clinical trials must be conducted with the addition of cognitive test batteries.

In collaboration with Cognitive Research Corporation (CRC), Altasciences designs and conducts specialized driving studies. Watch our experts explain in more detail.

Altasciences is a world leader in preclinical, clinical, and bioanalytical testing, and has been pioneering cannabis research for over 10 years in support of the FDA's strict guidelines on the use of the plant extract in medicinal products.

Sponsors partner with Altasciences in the early phases of their drug development program for our experience and innovative approach to evaluating the effects of cannabis on cognitive abilities.

Questions on cannabis studies, regulatory requirements, or how we can help with your early phase drug development program?

CONSULT WITH OUR EXPERTS

Companies developing biosimilars are collaborating with us because of our firsthand preclinical and clinical experience, distinctive recruitment strategies and speed in conducting biosimilar studies that require a customized approach based on the therapeutic indication and study-specific goals.

We have the scientific, toxicological, medical, and bioanalytical know-how to design studies that meet your objectives and timelines, manage any associated risks, and develop the methods required to analyze your product and its potential immunogenicity.

How we help move your biosimilar programs forward:

View our issue of The Altascientist on the topic and contact one of our experts to learn how we can help with your biosimilar programs.

BOOK A CONSULT

Since 2003, Altasciences has been designing, conducting, analyzing, and reporting on first-in-human (FIH) studies. We have conducted over 40 studies in the last three years alone, on both small molecules and biologics, in the U.S. and Canada. We are accustomed to reviewing preclinical data to design safe and efficient studies. Our sites have extensive, effective processes to protect subject safety, and well developed systems to quickly compile the data needed to make the decisions for dose escalations and adaptive design changes in SAD or integrated SAD/MAD trials.

We routinely include proof-of-concept arms using models with healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Our processes and large participant database successfully match study requirements and facilitate rapid recruitment into FIH studies. Patient populations that we have recruited for FIH trials include dyslipidemias, obesity, T2DM, psoriasis, atopic dermatitis, and allergies. We have conducted FIH trials requiring as many as 18 cohorts with no recruitment delays following decisions to proceed to the next dose levels.

Our team of specialists provides high quality support for bioanalysis, and the full range of research services, including data management, statistics and medical writing. We work closely with you to meet your milestones, and ensure compliant, on time regulatory submissions for your drug candidates.

The European Medicines Agency (EMA) has updated its guidance on first-in-human (FIH) clinical trials. The objective is to help drug sponsors "transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products".

The EMA updated the guideline since trial protocols have become "increasingly complex" with more multiple ascending dose clinical trials and trials that often include different parts within a single protocol.

The updated guideline includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and the conduct of FIH/early clinical trials. It also includes guidance on the handling of adverse events in relation to stopping rules, and information on how to progress to the next dosing level. A new section was added entitled "Dosing selection for FIH and early clinical trials" to offer guidance on determining the starting dose for healthy volunteers and patients; criteria for dose escalation; defining the maximum exposure; moving from single to multiple dosing; and determining the route of administration.

View new guideline

At Altasciences, we are always aligned with the latest guidances for your FIH clinical trials. We place the safety and well-being of trial participants at the forefront of our drug development programs and ensure that we continuously apply the experience gained from over 200 FIH studies we have conducted.

We have built a robust feasibility process that closely considers the risks of every study we run, with particular focus on FIH studies. The process of evaluating and mitigating risks starts the day we first talk to our sponsor about the study and continues until we have dosed the last patient. Our audits by European regulators, such as MHRA, have consistently had positive results and have given us useful feedback on the safety requirements we must meet.

Altasciences has been at the forefront of bioavailability (BA) and bioequivalence (BE) testing for over 25 years. With extensive expertise working on a variety of compounds, we have an exceptional reputation for successfully conducting simple to complex BA/BE trials and have experience with regulatory agencies across the world.

We have a large pharmacokinetics (PK) database, which has supported the design and conduct of over 2 600 studies in hundreds of medications. Our PK database contains invaluable details of the design as well as the variability observed in previous studies, providing us with important data to calculate the required sample size. Our expertise covers the full range of drug administration routes, giving us a firm understanding of the specific PK requirements of each dosage form. We routinely develop and validate new bioanalytical methods for novel compounds so that we are ready when you need them. We have developed over 620 methods, all of which are reliable and reproducible, for your drug discovery and development.

Our fast recruitment and excellent retention rate will help you complete your study faster. With 600 beds at your disposal across three strategically located facilities in the U.S. and Canada, Altasciences has the capacity to conduct multiple-arm studies, or multiple studies at the same time.

Altasciences recently expanded its bioanalytical laboratory by adding space dedicated to ligand binding and cell-based assays, to continue to support and deliver quality bioanalytical solutions to our clients. The new, larger space is fully equipped to respond to the high demand of cell-based neutralization and functional assays for biologics and vaccines. We now have the additional capacity for cell lineage and functional immuno-phenotyping by flow cytometry to support both preclinical and clinical studies.

Bioanalytical Support for Your Large Molecules

Renowned for our vast experience in LC-MS/MS and Ligand Binding bioanalytical platforms, our team of dedicated scientists in both the U.S. and Canada provide a comprehensive suite of bioanalytical services, from discovery to preclinical to phase IV. They evaluate each request and provide customized workflows to allow accurate quantitation using the appropriate platforms (Mass Spectrometry and/or Ligand Binding).

Why do clients appreciate working with us? Because each bioanalytical phase of your study ― method development, validation, and sample analysis ― has a Method Development Expert and/or a Bioanalytical Principal Investigator with the appropriate scientific and regulatory expertise assigned.

Let's discuss your bioanalytical needs and how our solutions can support your preclinical and/or clinical research.

Altasciences offers:

• Clinic locations in the U.S.A. and Canada to serve an international client base
• Studies that meet regulatory requirements for North America, Europe and several other countries
• Research designed to ensure consistency in application and accuracy of readings, to bring you reliable data, fast
• Studies and techniques piloted to clearly delineate operator and study challenges, and assure process efficiencies
• Robust database of over 225,000 participants with excellent retention rates, allowing for speedy recruitment
• Accurate readings with specially calibrated pipettes and highly sensitive chromameters
• Data management and medical writing according to your specific needs

Demonstrated Expertise

• More than 27 topical vasoconstrictor studies conducted with over 1,200 participants
• Rigorous study protocols, protected application sites, highly qualified staff, to deliver clean and reliable data
• Experienced operators with reproducible techniques participate in formalized training programs developed with industry experts

Data Management

• Team with over 20 years’ experience
• CDISC standards fully integrated into workflow
• Database lock typically 2 to 4 weeks after last subject visit