Did you know that Altasciences’ Material Management Team has over 25 years of experience? Indeed, our experts in sample management processes have been supporting clinical trials worldwide for over two decades.

We have designed an efficient system for accurate and safe clinical sample preparation, collection, and shipment from trial sites to bioanalytical laboratories.

You may also be interested in the following:

• Fact Sheet: Clinical Sample Collection Kits Capabilities
• Webpages: Bioanalytical Services, Clinical Services

With extensive expertise in a wide range of study types and therapeutic areas, Altasciences’ clinical monitoring and site management teams deliver reliable data, fast. Our experts work closely with you and your sites, to guide you through the complex steps of drug development.

Clinical Monitoring:

Highly skilled clinical research associates oversee all aspects of your clinical trial conduct to ensure data integrity, patient safety, protocol compliance, and GCP.

Site Management:

Experienced project managers oversee the conduct of multi-site programs in close collaboration with key internal and external stakeholders, ensuring seamless and timely communication.

Whether as stand-alone or part of an integrated program, let’s discuss your clinical monitoring and site management requirements today.

Speak with an expert

Have 5 minutes? You may be interested in:

• Impaired Renal and Hepatic Function Trials Capabilities
• Full-Time Equivalent Capabilities
• Research Support Services Capabilities
• Integrated Drug Development 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 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.

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.

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’ 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.