Our Solutions

25+ Years’ Experience Conducting Early Phase Drug Development

 

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:

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.

Working as a flexible, attentive extension of your team, we offer comprehensive drug development services to move your molecule forward.

Sign up for exclusive content

Join our list of 10,000+ VIP members and have access to our exclusive content.

You can unsubscribe at any time. For more details, please review our privacy policy.

Stay connected