Frequently Asked Questions

What is the process for getting a clinical trial project started

We start off with the final clinical trial protocol. We will mock up the CRFs for the clinical trial based on the CDISC standards and hand off a mobile app as our final product. We also provide a analytics app, this app gets populated with real-time trial metrics till the end of the drug trial.

What is your pricing model?

We charge a fee for configuring a drug trial for your study (protocol to study app) and then it is a software as a service fee for the duration of the drug trial. There are no need for software licenses or computer equipment, we provide the complete data platform on a per trial basis. If your trial does not work, you can stop the trial - close out the trial and stop paying us.

Is my data safe?

We use encrypted passwords for logins. Secure storage is in a HIPAA compliant cloud server and the data movements form the tablet to the cloud, and back is fully encrypted.

Is the platform 21CFR part 11 compliant?

Yes the platform is fully 21 CFR Part 11 compliant. We have secure logins, full audit trail of all the data entered and changes made and physician sign off at the end of the trial.

Can I enter data in a computer screen as opposed to mobile app?

Yes we provide this option, but for most studies a mobile app is more than sufficient. And mobile app provides additional functionality that is not available on a computer (for eg. capture PRO, photographs and video)

Do you offer any additional services?

Yes, depending on the trial we can provide additional services (data cleaning and monitoring). We can also help you find you trial partners who can perform these functions for you.

I am a biotech startup, can you handle the entire clinical trial for us?

Yes we can. We are a perfect data platform for a startup or established biotech. We will handle all the trial functions from protocol to final report.

I am a medical device company, can you handle our drug trial?

Yes we can. We are a perfect data platform for a medical device trial. We will handle all the trial functions from protocol to final report. We can do this at a lower cost compared to a full service CRO/data platform.

I am a nutraceutical/cosmeceutical company can you handle our trial?

Yes we can. We are a perfect data platform for a nutraceutical trial. With built-in capabilities to capture PRO, photographs and video, we can run your drug trial in most efficient way possible and provide you with final study database.

Is your platform good for a Phase 4 or observational study?

The platform is perfect for a phase 4 study, we can collect the data through mobile apps, this can be a patient facing app where data gets entered remotely by the patient or entered by the physician at the trial site. We can run your study cost effectively and get you the study results you need to support your drug marketing efforts.

Can I mix and match from your product suite.

Yes you can. You can use just the eSource functionality or you can use two of our services (eSource and chatbots), you can choose any combination of products that we offer to fit your clinical trial.

You still haven't answered my question?

You can reach us at info@iclinical.co and we will do our best to resolve your doubts.