In this latest issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

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

Have a few more minutes? Check out these insightful resources:

• The Altascientist—CDISC Data Standards
• Fact Sheet—Comprehensive Research Support
• Blog—Data Management Excellence

Our Laboratory Sciences Compliance Group is focused on quality, as well as on delivering critical drug biomarker quantitation data throughout each drug development phase.

We provide you with:

• Regulated bioanalysis across a wide range of analytes, including small molecules, biologics, bioequivalence, bioavailability, drug to drug interaction studies, and oligonucleotides 
• Process audits and facility inspections
• Quality management systems
• RQAP-GLP Registered Auditors actively involved in the U.S. and Canadian regulatory communities (SQA, PRCSQA, CCSQA) 
• Risk assessment quality audit plans
• On-site inspections and study-specific audits
• In-house Regulatory Team to ensure trials are conducted per protocol and within ICH/GCP/CFR guidelines  
• Vendor qualifications
• SOP management
• GLP recognition-compliant archiving

You may also be interested in the following:

Join Dr. Kaylyn Koenig, on November 30^th, for a conversation about digital droplet PCR (ddPCR) in preclinical research, including how it compares to qPCR.
 

Register Now

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.​​​​

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.