Posts Tagged electronic data capture
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on February 27, 2014
Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.
Cloud has been a big buzz word, significantly impacting the economy, in the last few years. Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau. Worldwide public cloud services market will total to over $73 billion, by 2017. There is also simultaneous cloud-bashing. According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather. Most also believe they have never used it but over 95% of us have used cloud based services.
It is therefore important to understand what constitutes cloud based services. There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them. Further, for the most part they are autonomous and the user can perform the actions without going through the IT department. They are easy to use and on-site training will increasingly become a thing of the past. Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access. For instance, consider gmail. It can be accessed through desktop, laptop, tablet, smart phone etc. Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic. But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015. By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes. To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China! Cloud based services enable customers to pool their resources and save cost.
Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys. Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go. People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.
Clinical Data Trends
Spiraling costs have been a grave concern in healthcare. Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things. Increased costs for clinical trials will push the cost of drugs higher. On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs. Companies have pressure to cut the middle layers and manage clinical trials on their own. Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.
Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data. Clinical data has to be stored in a private cloud. Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system. It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions. It reduces time for data entry. ClinCapture is also flexible and can be customized and deployed rapidly. “We validate our software like medical devices are validated”, said Gicqueau.
Mobile is next major trend, as more data entries are happening through tablets and smart phones. Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later. Data entries can also be structured by getting patients involved. Data integration is another big challenge. Everyone hopes to make sense of the data and make meaningful use of the data. However, making sense of the data and putting it to good use remains expensive. Gicqueau said, meaningful data integration is another promise of the cloud.
Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform. With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies to manage clinical studies in a sophisticated manner, without high level programming skills. About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau. Paper has many pitfalls. Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs. CloudClinica is FDA compliant and it can scale.
Clinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy. The company is profitable, and has 30+ clients that include Gilead, Roche and others. Clinovo is now targeting small to mid-size companies, said Gicqueau. Current market of $2.3 billion can be rapidly growing in the coming years. MediData and Oracle are two dominant players but are relatively more pricey. Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau. The event was followed by Q&A.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on June 20, 2012
Thamar Draper, a 20 year pharma industry veteran with expertise in project management, clinical software implementation and training, and Senior Director of Professional Services at Omnicomm (www.omnicomm.com), talked about FDA guidance on clinical data standards at http://www.bio2devicegroup.org .
The current new draft of FDA Guidance on Standardized Study Data was released February 2012. The actual guidance is expected to come in 2013, NDAs are expected to conform by 2015, and INDs are expected to conform by 2016. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. The guidance guidelines apply to collecting the data in electronic format and to standardization of data itself. Also when moving data around or integrating systems, it should be standardized and validated. Sponsors should consider during planning phase of study which data standards are applicable. Conversion of data to a standardized format at a later date reveals errors that could have been fixed earlier. Therefore, conversion of non standardized data to standardized format at a later date, is discouraged. For clinical and non clinical studies, sponsors should describe in the IND, their plan to submit standardized study data. Draper is a subject matter expert in the areas of EDC systems, clinical data bases and clinical data standards and is actively involved with CDSIC, a global, open, multidisciplinary, non-profit organization that has helped establish these standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
FDA uses certain review tools to review data and they want to review data in the same software. All data collected in the study are required to be submitted. Data validation is required and includes guidance on identifying issues early in data process and use manual inspection for data deficiencies. Technical validation guidance pertains to edit checks to validate the data and Business validation guidance pertains to supporting the data with meaningful analysis and finding errors in the data.
Draper then discussed Omnicomm’s Electronic Data Capture (EDC) and eClinical technologies with standards for Library, Data Collection, Data Exports, and Data Analysis, that can effectively and efficiently help companies comply with FDA guidance while also expediting clinical decisions and submissions. The talk was followed by Q&A.