We evaluate and assess various clinical trials and indications by doing the following:
Evaluating the feasibility of a DCT
Consider the type of trial being conduct, the technology needed for a DCT, the regulatory requirements, and the patient population. Evaluate whether a DCT is feasible and appropriate for your specific indication.
Developing and reviewing DCT protocol:
These protocols outline the trial design, technology platform, patient recruitment and enrollment, data collection, and monitoring procedures. We ensure that the protocol is compliant with regulatory requirements and ethical standards.
Selecting a technology platform that can support the DCT
We consider the functionality needed, data security and privacy, patient and site user experience, and compatibility with other systems.
Making sure regulatory approvals are secured and are in place
This may involve assuring an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) application to the FDA has been obtained from regulatory agencies.
Recruiting and enrolling patients
Develop a patient recruitment strategy that leverages digital and social media channels, patient advocacy groups, and other targeted outreach methods to attract eligible patients.
Collecting and monitoring data
Use technology to collect data remotely from patients and monitor the trial. We ensure that data collected are of high quality and complies with regulatory requirements.
Analyzing and reporting results
We help analyze the data collected and report the results of the trial. We ensure that the trial results are disseminated to relevant stakeholders in a timely and transparent manner.