Watch the Ethnobridging Webinar On‑Demand

Altasciences recently released a webinar on ethnobridging studies in which Dr. Affrime demonstrates how ethnobridging can help minimize time lags in development of drugs destined for Asian markets. Included are detailed case studies on how to include ethnobridging in your early clinical development plans to safely speed up worldwide regulatory approval.

Watch the Webinar On-Demand

To learn how Altasciences can assist you with your clinical research program,  contact us today!​​​​​​

You may also be interested in the following webpages:

• Ethnobridging Clinical Trials
• Early Clinical Development Services — Phase I/II

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.

Planning Your First In Human Trial

Check out this issue of The Altascientist for your roadmap to successfully conducting FIH studies, including: 

• Determining the necessary regulatory interactions 
• Selecting the starting dose 
• Designing the trial 
• Planning for participant safety 
• Identifying and mitigating potential risks 
• Recruiting, educating, and retaining study participants
• Planning resources and conducting the trial
   

Download issue

You may also be interested in the following:

Webpages:  

• First-In-Human Clinical Trials
• Comprehensive Early Clinical Development Solutions 

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.

A Chat with Dr. Morelli

Altasciences has decades of experience designing, conducting, and reporting on early phase clinical trials. We have the scientific expertise and seamless operational processes to deliver quality data with speed and ease. 

Watch as Dr. Morelli, Chief Medical Officer, shares his first-hand experience and insight into Altasciences’ planning and conduct of your first-in-human, complex, and innovator clinical trials.

Want to know more? Speak with an expert about your FIH and other clinical research needs.

You may also be interested in the following:

Webpages: 

• First-In-Human Clinical Trials
• Comprehensive Early Clinical Development Solutions
• Altasciences’ State-of-the-art Clinical Trial Facilities

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.

Robust Sample Management

Read our latest issue of The Altascientist to better understand how we deliver reliable study results through robust sample management for your preclinical and Phase I to IV clinical studies, including:

• Customized processes
• Controlled environments  
• Standardized workflows for risk management
• Capability to handle a wide variety of matrices
• Stability testing

Download your copy, or listen to the audiobook today.

You may also be interested in the following:

Webinars:

• Sample Collection Kits and Lab Manual
• Bioanalytical Project Management
• Critical Sample Handling Processes for Clinical and Preclinical Studies

Podcast:

• Transitioning Novel Scientific Workflows to Routine Bioanalysis 

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.

Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. 

In this issue of The Altascientist, we uncover the following:

• Regulatory environment and challenges — DEA 
• Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs 
• Manufacturing considerations

Download your issue

For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time. 

Speak with an expert today for more information or to review your specific program requirements. 

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.​​​​

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.

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:
  • Clinical Trial Facilities
  • Bioanalytical Services
• Fact Sheet:
  • Pharmacy On Demand