Phase I experience data
7,400+
clinical trials supported
92,000+
trial sites enabled
1,350,000+
participants engaged
Safety is priority #1 in early phase studies
Safety is the foundation of every early-phase study, guiding critical decisions that shape the future of your drug’s development. Rigorous monitoring and regulatory compliance help identify potential risks early, ensuring patient well-being while generating the meaningful data needed for confidence in next steps. With the right expertise, you can navigate safety requirements efficiently – accelerating your path to later-phase success.
Clario supports your safety studies in multiple ways:
Cardiac safety monitoring
All drugs enter the bloodstream and circulate through the heart, which introduces the possibility of cardiac adverse effects. Evaluating ECGs for prolongation of the QT interval is essential because it is; a critical risk for detection in early development.
Clario’s Early Precision QT® (EPQT) methodology delivers highly precise ECG data to detect the smallest change and can help support a potential waiver for a future dedicated Thorough QT (TQT) studies.
Phase I certified sites
We work with a network of pre-screened, highly trained Phase I sites across the globe to collect reproducible, high-quality digital ECG data. These sites are continually evaluated to ensure they meet data quality standards.
Additionally, by working with well-trained and well-equipped sites, you will increase the potential to reduce study start-up time.
Regulatory and study design consulting
Even as you’re designing your pre-clinical studies, our team of experts can support your development strategy to transition into early phase clinical studies and beyond.
With a legacy of engaging with regulatory bodies to establish standards and guidance, Clario is uniquely capable of guiding you through the complex regulatory landscape and optimizing your studies for maximum impact.
Meet your E14 regulatory requirements early with EPQT
Small molecule compounds in development must undergo rigorous ECG testing for their potential to prolong the QT interval as defined in the ICH E14 Guidance. Our team can help you meet these requirements earlier and potentially save millions by avoiding a dedicated TQT study later in development.
Go beyond safety and get early signals on your drug’s potential benefits
Early-phase studies provide an opportunity to have a first look at the impacts your drug may provide. While these studies may have fewer patients enrolled, you can obtain preliminary insights to inform what endpoints may be valuable to pursue in later phase studies, and help with pipeline prioritization.
Clario offers accessible early phase efficacy and quality of life solutions with quick study starts, including:
eCOA clinical trial solutions
Early phase trials demand speed and precision, especially when collecting patient-reported outcomes. Clario eCOA offers rapid deployment, with pre-built, validated assessments that streamline study set up. This ensures high-quality data collection to support early insights into efficacy and tolerability.
Respiratory solutions
It can be challenging to obtain reliable lung function data in any study, but with a smaller patient population, it’s even more critical to collect high quality data to understand the potential benefits and side effects.
In addition to offering multiple modalities for lung function testing, we also provide training to site-based technicians to improve the quality of data collected.
Medical imaging solutions
Medical imaging in early phase trials delivers early proof of efficacy and quality of life impact through high-value modalities like MRI, PET, and CT. These tools provide clear, objective data even in small populations, helping you detect biological activity, track disease progression, and assess organ response.
The result: faster, more confident decisions, smarter endpoint selection, and reduced risk and cost in later phases.
See how Clario’s imaging solutions can accelerate your early phase decisions.
