Research Support
Top Scientific Resources of 2021
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With the year coming to an end, we rounded-up some of our most insightful scientific resources from 2021. Check out what you may have missed, discover more about our areas of expertise, and learn how we can help you accelerate your drug development program. |
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Have five more minutes? You may be interested in:
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Are You Looking for Help with Scientific Publications?
Scientific Publication Writing — Let Us Help!
Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication. Our solution includes writing for a wide range of therapeutic areas, for your preclinical to clinical research — as part of a full‑service program completed at our facilities or as a stand-alone offering.
Benefit from:
- Strategic publication guidance and content development for manuscripts, posters, and abstracts
- Expert review and editing of your pre-written publications
- And more!
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- Comprehensive Research Support Capabilities
- Scientific, Regulatory, and Strategic Guidance
- Full-Time Equivalent Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.
Start Your Clinical Trials Sooner
Our clinical trial experts set your drug development program up for success by proactively preparing and performing each critical moving part while others are underway. As a single source for early phase drug development solutions, we integrate and synchronize key CRO/CDMO activities, such as clinic-ready manufacturing, bioanalysis, clinical study conduct, and regulatory review, so that you’re always ready for the next step.
Check out how we do this and experience the difference.
You may also be interested in the following:
Webpages:
Fact Sheet:
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.
Up Close and Personal with Dr. Denise Milovan
Neuroscientist Dr.
Clinical Sample Kit Management
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:
Fact Sheet:
We Deliver Your Projects On-Time.
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.
You may also be interested in the following:
Webpages:
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.
Navigating SEND with Altasciences
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:
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.
Expertise to Support the Approval of your 505(b)(2) or Hybrid Drug Submissions
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
Fast and Reliable Data for Your First-in-Human Trials
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.
You may also be interested in the following:
- Fact Sheets:
- 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.
Five Things you Need to Know about Scientific Affairs
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.