July 14, 2014 Issue
The Most Powerful Name In Corporate News and Information
Tablet-Based eSource Solution for Automated Clinical Trial Workflows
CliniOps has developed an innovative next generation eSource
solution that supports offline electronic data capture for clinical trials.
CliniOps’s tablet-based solution enables pharmaceutical companies and
clinical research organizations (CRO) to execute clinical trials effectively
with a high degree of automation and focus on data quality, data compliance,
and protocol adherence through a controlled workflow. Cliniops’s innovative
features such as electronically signed consent forms and biometric
verification will have far reaching consequences in improving ethical
compliance, and transparency in research. Launched in Oct 2013, CliniOps is
a privately held company based in Fremont, CA, USA. For more information,
please visit: http://www.cliniops.com.
2000 Walnut Avenue, N 203
Interview conducted by: Lynn Fosse, Senior Editor,
CEOCFO Magazine, Published – July 14, 2014
CEOCFO: Mr. Pal, what is the concept behind CliniOps?
Mr. Pal: At CliniOps, we are addressing some pressing unsolved problems of the clinical trial industry, particularly related to inefficient and costly data collection, data quality and data compliance. Also, the dramatic expansion of clinical trial activities in the emerging world, has led to additional data & compliance challenges and hence opportunities for the e-clinical industry. Our proven tablet-based eSource solution, developed through our patent pending technology, allows for the seamless capture of trusted and secured data, from various study sites around the world, leading to increased protocol adherence and regulatory compliance. We have also introduced multiple innovations and integrations leading to a fully automated clinical trial workflow.
CEOCFO: How will you be able to do that?
Mr. Pal: Before I come to the solution I would like to focus a little bit on the data collection challenges currently faced by the clinical trial industry.
A major reason for the high cost and long duration of clinical trials is the due to the inefficient and costly data collection process. With the advent of electronic data capture (EDC) systems, it was expected that data collection would be cleaner, faster, and cheaper compared to paper based system. However, in spite of adopting EDC systems, various barriers to their effective use, resulted most sponsors to follow a hybrid approach using both paper and electronic means of data capture.
Most of the currently available EDC systems are web-based. Because of problems with internet access, it is often impossible or inconvenient to enter data directly into these systems during subject evaluation. Therefore, investigators complete paper case report forms, during subject visits, and later transcribe the information, employing data entry personnel, into the EDC system. Also, most EDCs are PC-based, and hence lack of a hand-held data collection device also prompts data entry into paper forms in a busy clinic environment. Lack of integration of EDC systems with medical devices and other clinical software also leads to dependency on paper and duplicate data entry.
Thus, this widely practiced hybrid data capture system leads to a requirement for source data verification (SDV). Monitors travel to study sites around the world to verify the accuracy of the data entered against original data sources and maintain regulatory compliance. This accounts for more than 30% of clinical trial time and costs. To reduce this enormous time and cost of SDV, the industry has adopted alternative approaches like risk-based monitoring. However, even sponsors undertaking risk-based monitoring strategies recommend 100% SDV of consent forms to avoid compliance issues. Instead of on-site verification, many companies have adopted cost-effective alternative approaches. For example, the study site faxes/e-mails or uploads signed consent forms to an internet portal for remote monitoring. However, all these processes are manual, labor intensive, and time consuming.
Now, coming to the question about how we will be able to address these pressing problems of the clinical trial industry related to data collection, data quality and data compliance, well, my answer is, by developing an effective and efficient e-source solution that will eliminate dependency on paper and thereby eliminate time and cost of SDV.
CEOCFO: What are you developing to make this process easier?
Mr. Pal: To address the data collection challenges faced by the clinical trial industry, I started CliniOps, to leapfrog to a tablet-based eSource solution ‘CliniTrial’, that’s compliant and supports offline data collection, through our patent-pending technology. Our user-friendly hand-held offline data capture system is compatible for use in a busy clinic environment and thereby promotes electronic data capture at source. This, coupled with powerful edit checks drastically reduces the need for SDV. We have also introduced medical device and software integration to further automate data collection at source. CliniTrial also has provision of biometric registration and electronically signed consent forms to not only bring about increased transparency in the subject recruitment and data collection process, but, to also reduce the burden of SDV. Thus, our vision is to develop a fully automated clinical trial workflow through technology innovation.
CEOCFO: To your knowledge, has something similar been tried or are other people working on a similar concept?
Mr. Pal: Number of clinical trials using EDC systems is rising. With an estimated $5 billion global market in 2018 and a compound annual growth rate of 23%, the EDC market has multiple players, in various capacities. To understand the value adds of a tablet based e-source solution versus the traditional EDC systems, it is important to understand the current products that can range from PC based to tablet based systems and from point solutions to enterprise installations. At present the EDC market is dominated by web-based systems such as Medidata Rave and Oracle Inform. But, due to the portability and ease of use in busy clinical environment, the newer tablet-based EDC systems are fast gaining popularity and are poised to change the way we conduct trials today. However, the major tablet-based EDC systems, such as BioClinica’s Express EDC and InTrial, only support online data capture. Thus, their use is still restricted to areas with reliable internet availability. Recently, OpenClinica has integrated with Mi-Forms that use digital ink and tablet for offline data collection. Data is then transmitted back into OpenClinica. But, Mi-Forms are heavily dependent on handwriting recognition technologies.
CEOCFO: What is the regulatory atmosphere surrounding what you are doing?
Mr. Pal: To comply with the FDA regulations EDC systems needs to be CFR Title 21 Part 11 compliant. They also need to be HIPAA compliant to ensure privacy and security of protected health information. Our e-source solution satisfies both requirements.
CEOCFO: How are you introducing the concept and what are you finding are some of the objections or accolades?
Mr. Pal: The greatest objections we faced were from monitoring agencies who conduct SDV. They saw minimization or elimination of SDV as a threat to their existence. It was bit of a challenge to make them realize that our mission was to help them optimize their time by enabling them to focus on more important compliance issues rather than concentrating on SDV. Also, some people in the industry were skeptical of our vision that paper based data entry can be eliminated. However, we were successful in demonstrating to them that our workflow based data entry system will help researchers to seamlessly capture data electronically, at source.
Apart from these, we received an overall positive feedback from the industry especially from sponsors and CROs. Several of our key features such as offline data capture, handheld device, electronically signed consent forms, biometric verification process, and device integration received special attention.
Regarding accolades, we were selected in the coveted ‘Top 50 Hot Companies’ at TiECon this year. We were also selected as a finalist for the ‘Speed Pitch Panel’, at EPPICon Annual Conference, earlier this year. I have also authored several articles on the data collection challenges in clinical trials, published in Drug Discovery News, Village Capital and The Doctor Weighs In. There are a few more articles awaiting publication soon.
CEOCFO: What is the plan for the next year or so?
Mr. Pal: Our next step is to actively pursue clients through various business development activities. We have reached out to faculties at various academic research organizations and universities, who conduct clinical trials. We are also actively pursuing some of the pharmaceutical companies and contract research organizations (CRO) for adoption and implementation of our product as part of their process.
Apart from these direct consumers, we are also exploring partnership opportunities with companies who are industry leaders and are heavily interested in delving into the life science domain especially in clinical trials.
Also, data analysis is an integral part of clinical trials and discussions are going on with some market leaders in this domain for possible partnerships to incorporate next generation analytics engine into our solution.
CEOCFO: Are you fully funded for the steps you would like to take next?
Mr. Pal: We have bootstrapped our growth so far, with some capital from the founding team. We are also having initial discussions with both angel and institutional investors who have shown interest in our technology.
CEOCFO: Why is CliniOps a company to watch?
Mr. Pal: Clinical trials account for 60-70% of the time and more than 90% of the cost incurred in drug development. The average drug-to-market time is about 15 years and costs a staggering $1.8 billion. On an average, the length of a trial and the per-patient clinical trial costs has increased by 70% in the past few years. About 86% of all clinical trials experience delays, thereby prolonging the entire drug development process. This leaves lesser time for the pharmaceutical companies to reap profit from their investments. Patents for these drugs have a fixed lifetime, before it becomes a generic drug. On an average it costs $8 million to the sponsor for each day delay to market. To make up for this loss, pharmaceutical companies are forced to raise the price of their drugs, the brunt of which is actually borne by the consumers.
Therefore, improving the pace of clinical trials could not only translate into considerable cost savings for drug developers but, could also shorten the bench to bedside time for effective therapeutic drugs. As I said before, a major reason for the high cost and long duration of clinical trials is data collection. Therefore, optimizing the data collection process can considerably reduce time and cost of clinical trials.
EDC systems have done little to reduce the huge cost of monitoring and data
collection that eventually leads to high cost of drug development.
Therefore, the need of the hour is for an EDC system that would delve deeper
into and address the problem of effective source data generation and
minimize data verification, through technology innovations. At CliniOps, we
believe that the clinical trial industry is ripe for disruption and we want
to be a leader in the tablet-based eSource space.
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