From trial sites to our labs, Altasciences’ Material Management Team has over 25 years of experience supporting clinical trials around the globe. We make it easy with efficient collection, preparation and shipment of clinical samples.

Each kit is adapted to your specific study needs, and allows for the storage and shipping of different matrices, such as plasma, urine, serum, and whole blood.

Download our fact sheet to learn more about our capability or
send us an e-mail and we will connect you with an expert within 24 hours.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

You may also be interested in the following:

Webpages:

• Clinical Trial Facilities
• Bioanalytical Services

Fact Sheet:

• Pharmacy On Demand

On-Time Delivery

Over the last 12 months, our project management team has played a key role in achieving a 99% on-time delivery success rate on your primary KPIs.

Altasciences’ high-quality project management is key to the success of your drug development programs, and is an integral part of our service offering. Our project management team has extensive expertise in managing studies for a wide range of therapeutic areas in small and large molecules, and will oversee every aspect of your study.

Partner with us to ensure seamless and timely communication for the successful completion of your project.

Contact us

You may also be interested in the following:

Webpages:

• Full-Time Equivalent Capabilities
• Tell Us Once™
• Clinical Trial Services

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

If you are struggling with getting SEND data, Altasciences can help. Our personable and accessible SEND team is ready and able to answer your questions throughout your SEND process.

As an active member of the CDISC SEND Consortium and Pharmaceutical User Software Exchange (PhUSE) nonclinical working groups, Altasciences contributes to the development of SEND standards and remains at the forefront of these evolving requirements.

Contact a SEND expert today and start saving time.

You may also be interested in the following:

• SEND FAQs: Ask These SEND Questions First 
• Webinar: From Guides to Rules and How They Impact Your SEND Requirements 
• Scientific Publication: The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)
• Webpages:
  • Preclinical Solutions
  • Bioanalytical Solutions

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

A generic molecule with a different route of administration, format, strength, or indication from the original reference product requires re-approval for market authorization, partly based on data from the original medicine, and partly on data from new clinical trials on the modified version.

Consult The Altascientist for a review of the requirements for such approval, including a case study outlining three key studies we conducted for a 505(b)(2):

Altasciences ensures a seamless process for your 505(b)(2) or Hybrid medicine submissions, with integrated manufacturing, bioanalysis and comprehensive research support services that can expedite your clinical trials.

Speak with our experts.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

You may also be interested in the following:

• Video (3 minutes): Fully Integrated Drug Development Solutions
• Fact Sheet: Multiple Award-Winning CRO
• On-Demand Webinar: Patient Centricity and the Evolving Role of Microsampling

Data gathered during first-in-human (FIH) trials is critical to making go/no-go decisions in drug development. At Altasciences, we provide you with: 

• Timely sample analysis and scheduling flexibility
• Rapid turnaround of PK/PD analysis between cohorts (within 48 to 72 hours)
• Excellent communication and information sharing between clinic and lab  
• Early proof-of-concept signals

Our focus on early phase research, our integrated preclinical, clinical, manufacturing, and laboratory operations ensure data is shared with full transparency. PK analysis is built into your program schedule from the start, and dosage adjustments can be accommodated for safe and quick
decision-making.

Partner with us to get quality data you can rely on, fast.

Contact us

You may also be interested in the following:

• Fact Sheets:
  • First-in-Human Capabilities
  • Bioanalytical Services
• Webpage: Pharmacokinetics/Pharmacodynamics Capabilities
• Podcast: Certificate of Analysis Essentials for Regulatory Bioanalysis

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

Q&A with Catherine Dussault, Director of Scientific Affairs

Successful early phase drug development studies are grounded in a strong scientific rationale, and a deep understanding of regulatory requirements. Altasciences’ Scientific Affairs (SA) team combines these critical knowledge bases to support sponsors in designing and conducting the most appropriate studies for their unique development program.

Catherine Dussault,  Director, Scientific Affairs, Altasciences

Read the five things you need to know

Catherine Dussault is the Director of Altasciences’ Scientific Affairs team. She has been with Altasciences since 2004; and is a senior scientific leader with a deep knowledge of regulatory framework for various drug development clinical research programs. Catherine has overseen over 2,000 clinical trials, including Phase I and II, FIH, bioequivalence, 505(b)(2), drug-drug interactions, QTc, and proof of concept, in both healthy normal and special patient populations. She has extensive experience in multiple therapeutic areas, such as central nervous system, GI tract and metabolism, cardiovascular, genito-urinary system and sex hormones, antineoplastic and immunomodulating, and anti-infective agents.  

A Seamless Experience, Thanks to Expert Scientific Project Management

From lead candidate selection to clinical proof of concept, whether for a single study or multiple programs, Altasciences’ Scientific Project Management team manages every study with your business priorities in mind.

Join Lauren Szczurowski, Executive Director of Scientific Project Management, in this on-demand podcast as she reveals how Altasciences makes outsourcing early phase drug development a seamless experience.

Listen to Podcast

Schedule a conversation with one of our Scientific Project Managers to review your questions and requirements.

You may also be interested in the following:

• Video: The Benefits of Tell Us Once™
• Video: Your Road to Proactive Development with Altasciences
• Fact Sheet: First-in-Human Trial Capabilities
• Webpage: Full-Time Equivalent Capabilities

We are your single solution for both clinical conduct and bioanalytical analysis. Partner with our scientific experts to seamlessly make your critical go/no-go decisions… and save both time and money.

We make the process smoother by:

• Dedicating a team of scientific experts who are best equipped to walk you through every step of your project’s development
• Using one integrated sample management system, Watson LIMS™, from study sample collection to bioanalytical analysis
• Providing rapid in-house study sample shipping from our clinical site to our bioanalytical labs
• Eliminating time loss for the reconciliation of samples
• Ensuring timely PK analysis of safety data needed for critical, key decision making for later stage studies

Need we say more? Start saving time, contact our experts today.

You may also be interested in the following:

• Fact sheets:
  • Clinical Sample Collection Kits
  • Clinical Solutions
  • Bioanalytical Services
• Webpage: Tell Us Once™

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

Anatomic and clinical pathology datasets are critical when evaluating safety and efficacy during the preclinical stage of drug development. They identify and characterize toxicity by different, yet complementary means. Our expertise in integrating both clinical and pathology datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans.

At Altasciences, our Anatomic Pathologists and dual-certified Anatomic and Clinical Pathologist bring many decades of combined drug development knowledge to support our integrated approach to safety evaluation.

Speak to our experts today.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

You may also be interested in the following:

• Fact Sheet: Preclinical Drug Development
• Fact Sheet: Small Molecule Safety Assessment
• Fact Sheet: Biologics Safety Assessment
• Video: Altasciences’ Animal Welfare Program
• Webinar: 2020 SEND Progress Update