Clinical Trials
Altasciences Adopts ClinSpark® as a New eSource Platform
Altasciences’ New eSource Platform — ClinSpark®
We are pleased to share that we have adopted the eSource platform ClinSpark®, created by Foundry Health, to support our never-ending focus on compliance, efficiency, and oversight in data collection.
From recruitment to database lock, ClinSpark® software will provide you, our valued clients, with access to your data in a fully validated system, compliant with 21 CFR Part 11.
We have successfully deployed the administrative recruitment portion of ClinSpark®, as well as validated and deployed the clinic module. Ongoing trials being conducted in the clinic with a live database will still be performed by transcribing data from paper source documents into Medrio. Upcoming studies will be handled in ClinSpark® as eSource and/or eCRF. Our study team will be in touch regarding any changes to your study.
A Frequently Asked Questions document is available here for your convenience.
The validation package is available electronically for client review and audit purposes, upon request. Please contact your Altasciences Project Manager should you wish to coordinate access to the validation documentation.
We are very excited to share this important milestone with you, and look forward to our continued partnership!
Sincerely,
The Altasciences Clinical Team
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.
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
Clinical Sample Kits — We Make It Easy
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.
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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:
Five Facts About Psychedelics for Mental Health
As the incidence of mental health issues increases around the world, most recently exacerbated by the COVID-19 pandemic that has pushed depression to nearly triple the rate
Top 5 Scientific Resources in CNS Clinical Trials - May 2022
Scientific Resources in CNS Clinical Trials
Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.
Here are some of our most insightful scientific resources in the area of CNS drug development:
- The Altascientist: Central Nervous System
Early phase development of CNS-acting drugs is a complex, challenging undertaking. In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development. Learn More
- The Altascientist: CNS, Psychedelics and Other Schedule I Drugs
In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More
- The Altascientist: Studying the Effects of Drugs on Driving
Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More
- Webinar: Navigating the Abuse Potential Evaluation of CNS-active Drugs for EU and U.S. Submissions
In this on-demand webinar, we discuss the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements. Watch Now
- Webinar: Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-active Drugs
This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy. Watch Now
Speak with an expert today to learn more about our CNS solution.
Have five more minutes? Check out these webpages:
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.
Seamless Bioanalytical Transition from Preclinical to Clinical, and Beyond
Seamless Bioanalytical Transition
Altasciences’ scientists move in unison with you, collaboratively, accurately, and efficiently, from preclinical to clinical, and beyond. Our team of over 260 bioanalytical scientific veterans is strategically located across North America, and has experience with a wide spectrum of biological matrices in both animal and humans.
Driven by your assay requirements, our program support includes LC-MS/MS, LBA OR HYBRID LBA/LC-MS/MS ASSAY platforms for:
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Have 5 minutes? You may also be interested in the following:
- Assay List — Over 685 Assays covering 650 Molecules
- The Altascientist — Validation of Immunogenicity Assays
- Webinar — Development of a Cell-Based Assay for Dual Purposes: to Support Drug Potency and Immunogenicity Characterization
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.
How Novel Data-Driven Treatments Are Improving Patient Care
PODCAST — How Novel Data-Driven Treatments Are Improving Patient Care
Special guest Dr. Michael Winlo, Managing Director at Emyria, joins us for a very insightful conversation about their unique programs and new patient care models. Emyria is a biotech company that brings together patients, clinicians, researchers, and medical innovators to develop data-driven, novel treatments for patients in need, including cannibidiol formulations.
Have questions? Speak with one of our experts.
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.
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Three Key Advantages of Conducting Early Phase Clinical Trials in North America: An Overview of the Webinar “A Hop Across the Pond”
Regulatory processes can be challenging, and potential solutions can be found in broadening your focus to include clinical sites in the U.S. and Canada for your drug development strategy. With an understanding of how regulatory agencies and market environments may differ, you will be in a better position to optimize your program. In Altasciences’ on-demand webinar, A Hop Across the Pond, Ingrid Holmes, Vice President of Global Clinical Operations, and Dr.
A Unique Approach to Project Management
The Benefits of Altasciences’ Unique Approach to Project Management
When you partner with Altasciences, you are assigned a dedicated
cross-functional project manager to seamlessly guide you from one milestone to the next — keeping your studies on track, throughout the lifecycle of your project.
In this complimentary webinar, learn about the benefits of Altasciences’ unique program management offering, including case studies and client testimonials.
You may also be interested in the following:
- Fact Sheet: Integrated Research Services
- Video: QUICK CHAT with Lauren Szczurowski — A Seamless Experience with Scientific Project Management
- Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.