Working together to test the efficacy of our intervention
For the past year, we have been working together with ShareCRF to carry out the clinical trials testing our intervention. We have found ShareCRF to be an ideal collaboration partner for startups, particularly because of their intuitive and flexible electronic data capture (EDC) application, which allows studies to get off the ground quickly, as well as the responsive support team.
Our Co-Founder, Dr. Anjali Raja Beharelle, had the chance to interview Álvaro Grajal to find out more about ShareCRF, and how they support startups.
A testimonial to our collaboration with ShareCRF
Prior to this interview, Anjali also spoke to Álvaro about how ShareCRF’s support has contributed to the success of our clinical trials. A video of that conversation can be found here: https://www.sharecrf.com/success-stories.
Interview with Álvaro from ShareCRF
For those of you who don’t know ShareCRF yet, can you please explain who you are and what you do?
My name is Álvaro, and I am the VP of Sales of ShareCRF.
ShareCRF helps any type of organization (Medical Device, Pharma, CRO, Biotech etc.) that performs research and conducts clinical trials to optimize their CRF design, data collection, monitoring and data analysis processes with our EDC application.
Why did you join/found ShareCRF?
Anyone who has had a sick family member or has been sick themselves knows that health is the most important thing in life, and that’s why I decided to focus on this area.
With a degree in computer science, I wanted to use my knowledge and expertise to help those who help us to live better, longer and provide quality in our live.
As I am not a doctor/researcher, the best I could do is to help those who are and simplify their life as much as possible, so they can really focus on what is important.
What solutions do you provide and for which customers?
What we do is to facilitate the collection and management of clinical data from any type of clinical trial, allowing to obtain higher quality data in less time and with the highest possible security. We do that through ShareCRF, which is an EDC platform that contains several modules or integrated applications (eCRF, ePRO, Randomization, Medical Coding) designed to achieve that goal.
At what point would you say that ShareCRF is or became a success story?
I truly believe it coincided with the start of the COVID-19 pandemic. At that time our platform was used in several clinical trials related to COVID-19. An essential factor in these studies was time, we needed to go as fast as possible, but without sacrificing the safety of the participants. That’s when we realized that our platform allowed us to launch a data collection system in a really short space of time. In some cases, we were able to do it in less than a week.
In March of 2022 you donated your platform and professional services to all non-profit studies related to COVID-19. Are there any great stories that you can share related this wonderful initiative?
As mentioned previously, helping others is what really motivates us, and COVID-19 hit all of us very hard. It was a situation that most of us never lived through before and those who were fighting first line against it to help the population were doctors and nurses in hospitals. So it was critical to start collecting data as soon as possible and we donated our platform to help as much as we could.
It was really beautiful to see how the research teams we collaborated with gave their best effort to accelerate COVID-19 related studies as much as possible.
More and more digital health startups like Collabree depend on clinical data to get market authorization and access to the different reimbursement tracks (e.g. DiGA in Germany). Have you also experienced or been affected by this trend?
It is true, that little by little more organizations are moving from old data collection systems such as those are paper based or in Excel to new electronic data collection platforms to conduct their clinical trials. This could be caused by the tightening of the regulations to be complied with, and I think COVID-19 also opened people’s eyes to be more receptive to modern methodologies. During the pandemic, a high percentage of projects had to put their clinical trials on hold because their old methodology did not allow them to continue, while our clients, for example, were able to adapt and continue their processes.
What are the differences when working together with smaller startups compared to bigger and more established companies?
I think the biggest difference is the greater “speed” of startups in implementing our platform and starting to use it. I would also highlight their greater agility to adapt to changes. Large companies usually have longer times and processes that make these adaptations or changes a little slower.
We as Collabree appreciate working with ShareCRF because of the flexibility you provide and the fair pricing model. Why should other companies choose ShareCRF when they are looking for a specific eCRF a-nd ePRO web platform, and do you offer any unique benefits for startups?
We believe that ShareCRF offers a unique combination of factors such as:
- Users do not have to learn and use a complicated system, but instead can use the system in an easy and intuitive way and avoid with these the users’ complaints for having a very complicated system.
- The quality of the data obtained is very high. By this I mean that the data collected is correct. This is possible without having to program anything and any person can configure the system. How is this achieved? By being able to have automatic edit checks and queries, among other things, in a simple way and that can be improved throughout the study whenever desired.
- Users can make changes in an ongoing study in a very fast and totally secure way.
- Users have a support team available that, when you contact them, they do not waste your time with a lot of emails, but they really help you and very fast.
The startups have an important benefit that comes from the calculation of the cost of the platform, as this depends on the number of patients to be enrolled in the study. This means that small studies are cheaper than large studies, and considering that the studies of startups are usually small, this allows them to start working with us in a simpler way.
You are constantly improving your platform and build new and helpful features. Can you share anything about the biggest new features in the upcoming releases?
I can let you know that next version of ShareCRF will have important improvements in the electronic Patient Reported Outcomes (ePRO) module, allowing ePRO forms to be enabled automatically. Previously, this could only be done manually. Also, the messages to the participants can be configured in detail, allowing to define when, and what content they should have, with the objective that the questionnaires are completed by all participants. We will also add SMS support for participant reminders, in addition to the existing email support.
In addition, we will include new enhancements that will allow defining when visits should be completed by participating sites and sending automatic alerts to these sites when these visits are not completed.
In the longer term, we have enhancements such as customizable reports on study data, which will allow you to create custom reports on the data collected, such as reports on adverse events, or on cohorts that you want to study within the study.
We also have improvements planned that will allow you to define groups of fields on which review actions should be performed, so that only labeled fields need to be reviewed. This is very useful to exclude from the review those fields that are e-source data such as ePRO fields.
In addition to all of the above, we are planning to create a new module that helps to facilitate the collection of data in SDTM format, to help our customers when submitting their study data to the FDA.
That all sounds great, we are vey much looking forward to all these new features and enhancements. It was a pleasure talking to you Álvaro. Is there anything you would like to add?
Nothing more. Thank you for this interview. It has been a pleasure to answer your questions, and we hope that all your clinical trials meet the expected objectives.
Álvaro Grajal
VP of Sales and Co-Founder of ShareCRF
