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Dr. Anne Marie Salapatek, MSc, PhD, Chief Scientific Officer & Executive Vice President
Cliantha also has a high throughput outpatient clinic with the capacity to screen hundreds of patients per day, operating seven days a week with flexible hours. Its phase I unit comprises 60 beds and an Intensive Observation Unit to conduct FIH and BE/BA studies. As such, the company’s clinics can provide extraordinary services to recruit and study hundreds of patients, removing the need to have multiple sites. In addition, it has a bioanalytical lab in Toronto and a consumer research facility in Winnipeg.
“We work with drug developers across the globe to leverage the advantages of trial conduct in Canada, such as the study population, deemed representative of U.S. and European populations, and the need for only a study-specific clinical trial application with no requirement to make an Investigational New Drug (IND) application or commitment to the market in Canada,” says Dr. Anne Marie Salapatek, Chief Scientific Officer and EVP, Cliantha.![]()
I am proud of our EECs operated by our expert staff. In the past three decades, they have allowed many new products to come to market quickly, helping the sponsors as well as patients
This also provides Cliantha’s sponsors with greater flexibility to gather invaluable insights that can support a subsequent U.S. IND submission.
For instance, one of Cliantha’s clients was aiming to bring an oral product for allergy—already approved in Japan—to the North American market in a nasal spray formulation. The company spoke to the client together with Health Canada and looked at the whole package to accumulate all the critical information regarding the product.
This ability to fast-track the approval process is rare in the industry. Cliantha is capable of achieving this feat due to its knack for having early interactions with clients and understanding the products on the molecular level. Salapatek, in fact, engages early in every client conversation to understand their requirements and customize the right solution accordingly.
Cliantha always strives to undertake a forward-looking approach to constantly innovate in the CRO space. Some of its innovations include the world-class Environmental Exposure Chambers (EECs), which allow the company to conduct clinical studies for a variety of disease indications and drug formulations.
EECs have been used for over three decades to support new drug development in all phases. They play a vital role in ensuring successful outcomes for new drugs and generic allergy and asthma medications. EECs mimic Mother Nature’s release of airborne allergens but in a more reliable and controlled fashion. This holds immense importance today when climate change contributes to unreliable pollen release leading to trial failures and increased developmental costs to extend or repeat the trial.
Most recently, Cliantha has expanded its offerings to bring its extensive clinical experience and innovation to consumer research and provide Consumer Clinical services. Clinical consumer trials are an emerging need for personal health care companies. Consumer Clinical trials support label claims, an OTC switch, or generally provide a more objective and rigorous approach than in-field, survey-based research. In fact, Cliantha acquired Hill Top Research, a pioneer in this field who has been conducting consumer research since 1947.
“I was attracted to Cliantha Research North America and the global Cliantha Research Group overall because of our quality commitment and ability to bring efficiencies and cost savings to healthcare and drug development. Imagine having an EEC (chamber) capable of conducting a clinical trial that might otherwise require multiple sites, remote monitoring visits, and vast infrastructure. We do it in one of our supersites without any additional cost,” says Stuart Goldblatt, President and CEO of North America, Cliantha.
Cliantha also utilizes EECs to study Dry Eye Syndrome, the impact of nasal inflammation on the bioavailability of nasal sprays on allergic patients, and environmental irritants, including pollution, volatile organic compounds, and thermal and barometric pressure shifts.
“I have applied my scientific expertise and clinical experience to the clinical trials we conduct at Cliantha. I am proud of our EECs operated by our expert staff. In the past three decades, they have allowed many new products to come to market quickly, helping our sponsors as well as patients,” says Dr. Salapatek.
Company
Cliantha Research
Management
Dr. Anne Marie Salapatek, MSc, PhD, Chief Scientific Officer & Executive Vice President
Description
Cliantha Research is a global, full-service CRO providing clinical research services across the entire drug development clinical phase life cycle. Cliantha’s innovations include its world-class Environmental Exposure Chambers (EEC). These EECs are the facilities where Cliantha can conduct clinical studies for various disease indications and drug formulations.