One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral. 

Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.

We facilitate drug development and save you time by:

1. Preparing your preclinical study designs, including species selection and dose level determination.
2. Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
3. Writing your IND/CTA applications.
4. Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
5. Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
6. Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
7. Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
8. Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.  

Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.

Speak with our experts.

You may also be interested in the following:

• Video: Your Road to Proactive Drug Development with Altasciences
• Webpage: Scientific, Regulatory and Strategic Guidance
• Webpage: Full-Time Equivalent (FTE) Capabilities

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.

Anatomic and clinical pathology datasets are critical when evaluating safety and efficacy during the preclinical stage of drug development. They identify and characterize toxicity by different, yet complementary means. Our expertise in integrating both clinical and pathology datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans.

At Altasciences, our Anatomic Pathologists and dual-certified Anatomic and Clinical Pathologist bring many decades of combined drug development knowledge to support our integrated approach to safety evaluation.

Speak to our experts today.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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:

• Fact Sheet: Preclinical Drug Development
• Fact Sheet: Small Molecule Safety Assessment
• Fact Sheet: Biologics Safety Assessment
• Video: Altasciences’ Animal Welfare Program
• Webinar: 2020 SEND Progress Update

Dr. LaFollette from NA3RsC Talks Animal Welfare!

Altasciences’ important role in the drug development process comes with the significant responsibility of ensuring the welfare of our research animals, a responsibility that we take extremely seriously.

Altasciences is committed to doing everything possible to minimize the number of animals used and ensure that the animals used are treated with care, dignity, and the utmost respect.

Dr. Christina Cruzen, Attending Veterinarian and Chief Animal Welfare Officer, had the opportunity to interview Dr. Megan R. LaFollette, Program Manager at The North American 3Rs of Animals in Research Collaborative (NA3RsC), to discuss the importance of animal welfare, the 3Rs, how the role of animal research is changing, rat tickling as a refinement technique, and much more.

Enjoy the interview!

Contact Dr. Cruzen to further discuss all things animal welfare.

You may also be interested in the following: 

• Video: Feel the Love ― Altasciences' Animal Welfare Program
• Webpage: Full-Time Equivalent (FTE) Capabilities
• Insert: Bioanalytical Services ― General Overview

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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. 

Altasciences can initiate rodent toxicology studies in 4 to 6 weeks. As soon as your contract is signed, our experienced team of toxicologists will work closely with you to develop and employ strategies to help move your molecule through the drug development process as quickly as possible, by proactively identifying potential challenges and planning accordingly. 

Selecting the right CRO for your studies is critical to the success of your research.

Make the right choice, contact us today.

You may also be interested in the following:

• The Altascientist: Planning your Preclinical Assessment
• The Altascientist: Safety Pharmacology Studies ― a Review
• Insert: Bioanalysis of Small Molecules
• Video: Your Road to Proactive Drug Development with Altasciences
• Webpage: Tell Us Once™

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.

In this on-demand podcast, Dr. Christina Cruzen, Attending Veterinarian and Chief Animal Welfare Officer, discusses how Altasciences’ commitment to the 3Rs remains a priority and how it pushes us to continuously advance our animal welfare program. 

Here are some examples of recent advancements made to the program:

• Partnered with North American 3Rs Collaborative
• Increased the role of the animal behaviorist to help guide specific study needs
• Established a more robust technical review process by involving a new cross-functional committee
• Further refined procedure cages to better fit animal needs

Listen to this podcast to learn more about how Altasciences’ prioritizes animal welfare to ensure the wellbeing of the research animals in our care.

Questions? Speak to an expert.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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:

• Video: Altasciences’ Animal Welfare Program
• Webpage: Scientific, Regulatory and Strategic Guidance
• Insert: Bioanalytical Services

We are ideally positioned to support an efficient, rapid, IND submission to the FDA — for a review of the IND requirements, consult our Preclinical Assessment Planning Guide. Your submission needs to contain comprehensive information in three critical areas:

• Animal pharmacology and toxicology studies 
• Manufacturing for producing the drug substance and the drug product
• Detailed protocols for proposed early clinical studies, including clinical investigators, necessary documentation and reviews, all within IND regulations

Altasciences’ Proactive Drug Development platform seamlessly integrates all of these key services, preclinical, manufacturing and early phase clinical, within an integrated partnership.

Contact our experts today.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.

You may also be interested in the following:

• Video: Preclinical Services
• The Altascientist: Safety Pharmacology Studies – a Review
• Fact Sheets: 
  • IND Services for Small Molecules
  • IND Services for Biologics