Collaboration and communication means quality documentation for your drug development program. Our Medical Writing teams collaborate constantly with our experts and yours, ensuring that very scientific document required for your study is accurate, complete, and-compliant with regulatory guidance. From initial protocol to the final clinical study report, we deliver rapidly, without compromise.

As a stand-alone solution, or part of an Altasciences study program, our Medical Writing team is ready to support you. You can work in unison with us on a Full-time equivalent (FTE)basis, or project by project, the choice is yours.

CDISC and SEND Simplify and Expedite Study Data Interpretation

Read The Altascientist and see how CDISC and SEND standards simplify and speed up analysis of your data, facilitating regulatory review and increasing your access to the power of big data. Includes two illustrative case studies and comprehensive FAQs.

Speak with an expert to learn more about our service offering.

Have five minutes? Take a look at these:

• Fact Sheet: Comprehensive Research Support Offering 
• eBook: One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
• Webpages: 
  • CDISC Offering
  • Research Support 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.

Trust Altasciences to Deliver the Quality, Compliant Data You Need

How do we collect data? With much planning!

Your study plan documents complement your protocol, and provide additional details for data management and analysis.

Our data managers plan for quality, clear data in support of your regulatory submission. Single- or multi-site, in a wide range of therapeutic areas, our decades of experience will deliver the data you need.

Let’s talk data—contact our experts today!

Have an extra minute? Take a look at these:

• Blog: Data Management Excellence–What it Takes
• Webpages:
  • Data Management Offering
  • Research Support Services

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.

Phase I and II Combined Protocols Can Give You Earlier Access to Important Data—Here’s How

Have you considered combining Phase I and II protocols to advance certain analyses? Think DDI, QT assessment, food, age, or gender affect, or cognitive or dependence evaluation. With earlier access to this highly relevant data, you have the power to make more informed decisions as you progress your drug through development, and possibly obtain a waiver for certain later-phase studies.

Our experts in protocol development are ready to design your ideal program, giving you the earliest, most complete understanding of your developmental product.

Read The Altascientist for a more complete discussion on combined protocols, including two scenarios.

DOWNLOAD your copy, or listen to the AUDIOBOOK.

Have five more minutes? Browse these webpages for more important information:

• First-in-Human Clinical Trials
• Early Phase Drug Development Solutions
• 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 service

Scientific Publication Writing — Let Us Help!

Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication, 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!

Let’s get started!

Have 5 minutes? You may be interested in:

• 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.

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.

Quick Chat with Roland Jbeily, Regulatory Affairs Manager

Altasciences’ Regulatory Affairs team has significant expertise with regulatory bodies in both the U.S. and Canada. In this interview, Roland Jbeily discusses how our Canadian operations works as a bridge between sponsors and Health Canada providing strategic guidance to colleagues and sponsors to help advance drug development with speed and ease.

Watch the full interview and get through the CTA process with confidence: ​​​​​

Watch video

You may also be interested in the following:

• Integrated Research Services
• Webinar — Discovering the Many Advantages of Conducting Early Phase Clinical Trials in North America
• The Altascientist — Planning Your First-in-Human Trial

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.