February is Heart Month, a time to raise awareness on cardiovascular health. Cardiac safety issues are one of the main reasons promising drugs are halted in development.

With the collaboration of a number of leading core ECG vendors and our in-house clinical units specially designed for assessing cardiac safety, Altasciences has designed and conducted over 30 early cardiac safety and QT prolongation studies.

Whether you choose to conduct your cardiac assessment trials earlier (such as in first-in-human studies) or a little later (after completing Phase II), you can benefit from the following advantages:

In this issue of The Altascientist, we discuss the ICH regulations, and provide a thorough review of the design and timing of QT studies for your drug development program.

Included is a recent case study on the QT assessment in a novel cannabis trial involving 80 subjects.

Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the required preclinical studies to first-in-human trials?

With over 25+ years of extensive experience conducting clinical trials and strategic alliances with a number of leading research centers, ,Altasciences is the best partner for studies requiring access to a large database of patients with metabolic disorders.

We have completed over 50 studies to date. Our database of over 345,000 participants includes:

In a recent NASH study, Altasciences had the best recruitment numbers out of 10 global sites recruiting for the study, even though we were included in the recruitment process only two months after the other sites. When the overall objective was met and recruitment was stopped, we had recruited more than 30% of the patients.

We have much more to share, including a Q&A session on clinical trials for metabolic disorders with an expert in the field, our end-to-end recruitment process, and a case study on diabetes.

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The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression.

In this issue of The Altascientist, we discuss:

• Advantages of working with one CRO from preclinical to clinical
• Key aspects in designing a successful FIH trial
• The importance of having quick access to special and patient populations
• How adaptive trial designs in FIH studies can save drug developers significant time and millions in program costs
• Case study: Adaptive, FIH trial to assess safety, tolerability, PK, and food effect of single and multiple ascending doses (SAD/MAD) of a novel small molecule

Altasciences has designed and conducted a large number of renal and hepatic impaired studies and provides a flexible approach that allows for customization depending on your unique study needs. We partner with leading external sites to ensure that our renal and hepatic impaired patients have the specialized clinical oversight needed, and we leverage their databases to ensure we access the patient populations your studies require.