Rare disease clinical trials

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Rare disease
clinical trials

The barriers to advancing scientific research in rare disease are high due to the severity and disabling aspects of the condition, the lack of existing treatments, and the scarcity of adequate scientific data.
Rare disease clinical trials are often more complex than traditional clinical trial designs. They require significant additions, on top of conventional measures, to broaden the information collected and address aspects of the disease that are relevant to the patients and to their unique histories.

At Kayentis, we ensure the incorporation of meaningful outcomes, symptoms, and aspects of the disease that matter to patients and families.

Strengthen your rare disease clinical program with our eCOA early strategic support

With extensive experience in rare disease clinical research, we provide strong strategic advisory support from the very start of your clinical development plan.

Our eCOA strategy advisory board helps you define your clinical program endpoints, select the most appropriate PRO instruments, and determine the optimal frequency for the administration of questionnaires to ensure a successful trial.
Our specialists also help you define your eCOA strategy based on the latest regulatory approvals and labeling claims. They collaborate with you to develop the eCOA portion of your protocol.
Our team can partner with you to design study-specific eDiaries as a further means of capturing the patient perspective. These eDiaries can be tailored to track various aspects of the disease or treatment impact, such as symptom severity or pain, on a daily basis, and to monitor the evolution of a symptom throughout the trial.

Optimize your rare disease clinical trial with highly professional operational guidance

The development of innovative treatments targeting unmet medical needs requires experienced, dedicated teams and reliable partners:

Expect a high level of support from our teams for the implementation and management of all operational activities related to your study.
Rely on our full service, including questionnaire translation and certification, licensing management, logistics, and helpdesk support.
Monitor your eCOA data instantly through our Clin’form WebPortal and adjust your strategy accordingly.
Obtain specific, customized data reports and dashboards tailored to meet the unique needs of your rare disease clinical trial.

Support your rare disease study patients with our patient engagement program

Rare disease patients are scarce, making their input to clinical research highly valued, and engaging with such patients every day is instrumental to the success of a clinical study:

Benefit from our patient training and supportive materials from study start.
Co-created with patients, study engagement materials can be made available to help rare disease study patients understand the value they bring to a clinical study, thereby improving patient engagement and compliance.
Give your study patients the option of completing their ePRO using their preferred data collection method, to ensure data quality and accuracy.