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 work with you to 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. Once the trial starts, app gets populated with real-time trial metrics.

What is your pricing model?

We provide our data platform as a service. We charge a setup fee for configuring our data platform for your trial (protocol to study app) and a software as a service fee for the duration of the trial (if the trial stops prematurely for any reseaon, you stop paying us! There are no need for expensive software licenses or computer hardware purchases, we provide the complete data platform to get you started on your trial from day 1.

Is my data safe?

Our data platform meets FDA 21 CFR Part 11 requiremnts. We use encrypted passwords for logins. Secure storage is in a HIPAA compliant cloud servers. Data movements form the app 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 trial data and investigator signatures to certify authenticity of the trial data

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 (Eg. Capture PRO data, 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 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 individual products from your platform.

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 needs.

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.