Tag Archive | Mobility

Mobility – HTML 5 vs. Native Apps

Building native applications for mobile devices is like building a ‘Client-Server’ application which was popularized in the 90’s and 00’s with the explosion of personal computers. While this trend leveraged the fact that an application can use the computing power of the client device and provide better user experience and performance. However, from a maintenance perspective this was a nightmare. I still remember the “DLL Compatibility” issues driving me and my team crazy when we were deploying these applications in an enterprise environment and having to update/upgrade the application frequently. It generated a lot of call volume to the support teams. Combine that with the lack of good collaboration tools and you have a perfect storm whenever there is a new release.

The reason I bring this up is that the web has changed this whole ‘Client-Server’ paradigm and drove the application development model to adopt web-based architectures. With respect to Mobile Application Development we are looking at another such paradigm shift where there should be more and more applications built using ‘HTML5’ based app development for mobile devices. Just as in the case of Client-Server apps, ‘Native Apps’ for mobile devices provide a lot of power for developers to build apps that provide better user experience and performance, but it is a maintenance nightmare and also tend to increase the deployment cycles. A ‘HTML5’ application that follows the “80-20” rule and uses 20% native code will provide greater flexibility by delivering almost all the advantages that a ‘Native App’ would. Plus, it also fits into the “Build Once Deploy Anywhere” model where the app can be deployed to multiple mobile devices (iOS, Andriod, Blackberry, Windows Mobile etc.) with minimal changes (to the 20%) of the native code (all the HTML5 code doesn’t need any platform specific changes).

This approach is being recommended by many analysts, thought leaders and vendors. It would be interesting to see how many developers adopt this approach and accelerate the shift in Mobile Application Development paradigm.

Advertisements

Patient Reported Outcomes and Mobile Solutions

As stated in some of my previous posts, I have been working in the Life Sciences industry for over 8 years now. That amounts to a little bit over half my career till date. It has been a good journey with appreciation towards the greater good that this industry does in making people’s lives better. I agree that there is an image problem due to multiple incidents that compromised patients’ safety for profits or other trade-offs. However, all in all I personally think that there is much more good done than harm.

One thing that Life Sciences industry is not is “being technologically savvy”. Even this statement, if applied with in an organization, the degree of applicability changes from one business unit to the other. More than that, it has to be stated that the units that are “more regulated” are much behind in new technology adoption. The units that I have been working with the most is Research & Development (R&D). Even within this unit, the Research Teams, specifically Drug Discovery teams are more open to adopting new and advanced technology compared to the Drug Development teams.

As part of my day job, one of my goals is to continuously monitor new technology trends, specifically within the Life Sciences realm and help our teams develop new solutions and services. Identifying the solutions to be developed is not an easy job considering the economic constraints under which most companies are working in this “New Economy”. Luckily for me, another goal of my job is to find the right partners who would help us develop these new solutions and services so we can go to market faster.

One such partnerships is with a company that developed a Mobile Solution to enable Patient Reported Outcomes (PRO). I did a joint Webinar with them today titled “Maximizing Patient Reported Outcome (PRO) compliance in Clinical Trials – Leveraging Mobile Solutions“. While trying to put together a presentation that highlight the trends in Mobility adoption in general and adoption in Life Sciences and specifically Clinical Trials, I found out some surprising facts that the Mobile industry will be growing at a CAGR of 15.6% for the next 5 years (IDC Press Release).Also, according to another IDC report, Smart Phones will out sell the Netbooks, Desktops, Laptops and such combined in the next couple of years.

Patient Reported Outcomes (PRO) is all about getting information directly from the patients, without any interpretation  by specialists. In fact, FDA defines this as “A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response“. In my opinion, it looks obvious that leveraging the Mobile devices to run PRO trials improves the overall quality of data as well as the response time, not to mention the compliance to a large extent. The key is the coverage of last mile, i.e. enabling the patients to be reminded of any delays in submission of assessments. This will also open up a more personal service channel that can be leveraged to build a closer relationship with the patients.

As with adoption of many other disruptive technologies like Social Media, Cloud Computing etc. the regulatory compliance questions need to be addressed for any solutions developed to be used on Mobile devices. You can refer to my previous post titled “iPads, iPhones, Androids, Windows Mobile Phones, Life Sciences and Compliance” on what are the regulatory compliance requirements (specifically, guidance by FDA) to be considered in this context. The key is to ensure that the patient data collected is secure and the solution works in situations where the patient does not have connectivity. Also, the overall cost of the trial would come down considerably if the protocol permits ‘Bring Your Own Device (BYOD)” model for patients participating in the trial. Of course, this depends on the nature of the protocol and the trial design.

All in all, with the phenomenal up tick in Smart Phone sales, more so in ‘Pharmerging” markets like India and China which are also becoming the “Hubs” of future growth for Life Sciences companies, it is essential that Mobile solutions be developed and used to cover the last mile i.e. for the user touch points like Physicians, Patients and Pharmacies.

As always, your feedback and comments are welcome. I also encourage you to share Pros and Cons of the adoption based on your practical experience. I will be even more interested in any technological challenges you may have come across in the adoption process.

Risk based monitoring and SDV – Increased adoption of ECM

It is universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs.

Key Trends:

Risk Based Site Monitoring:

US FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”. As per the document its overarching goal is to “enhance human subject protection and the quality of clinical trial data”. However, it clarifies on the strict interpretation that the industry has assumed long back and has spent billions in monitoring the sites. While this is draft guidance it is more than likely that this will end up in establishing the guiding principles for central monitoring of clinical trials, as such is the intent.

Risk Based Source Document Verification:

Primary activity of site monitoring is the source document verification and as was the case in site monitoring, industry has been mostly using the strict interpretation of source document verification. This resulted in 100% of source documents (patient eCRFs) being verified by the site monitors. However, the industry has realized that “law of diminishing returns” applies to this process as well and has been reducing the percentage of documents verified by the monitors. Medidata’s Insights “Targeted Site Monitoring Trend Snapshot” published in Applied Clinical Trials website confirms this trend.  According to this report the SDV percentage has reduced from 85% in 2007 to 67% in 2010.

Virtual Clinical Trials:

Another key trend that is slowly evolving in this context is complete virtualization of clinical trials. Pfizer is taking the lead in this space. While Pfizer’s REMOTE program is ongoing, an interim feedback from the program is provided by Mr. Craig Lipset, Head of Clinical Innovation at Pfizer is provided by Applied Clinical Trials in their article titled “Pfizer’s REMOTE Virtual Experience”. As highlighted in the article, they are going through the roadblocks of an early adopter.

Adoption of Enterprise Collaboration and Content Management:

Electronic communication and collaboration:

The above trends indicate that it is just a matter of time that total virtualization of clinical trials is accomplished. The key question that needs to be addressed is “How will the human interactions be virtualized?” The answer is “to adopt electronic communication and collaboration channels”. The channels can range from adopting systems to capture and manage clinical data, electronic source document verification to seamless communication and collaboration tools. The unique constraint with respect to clinical trials though is to ensure that the tools used adhere to “Good Clinical Practices” as well as other regulatory requirements like 21 CFR Part 11, HIPAA etc.

Enterprise Collaboration and Content Management Systems:

Systems for Electronic data capture (EDC), Clinical Data Management (CDM), Clinical Trial Management System (CTM), Adverse Event Management etc. are already available in the market. The key tool that would make it easier to seamlessly transition from human interactions to virtual interactions, in my view, is an Enterprise Collaboration and Content Management tool. Tools like Microsoft’s SharePoint, as highlighted in one of my previous blog posts, will help organizations make this transition fast and cost-effective. While it is always easier said than done, from real world experiences that we already have, it is relatively easy to adopt these tools in a GxP environment, meet all the regulatory compliance requirements and also accomplish the degree of flexibility required to easily communicate and collaborate.

Social Media and Mobility:

A couple more initiatives that could complement in the process are Social Media and Mobility. The need for a social media outreach program to increase the patient recruitment is highlighted by the channels Pfizer’s REMOTE program has adopted.  On similar lines, social media “like” features can be enabled on the collaboration and communication platform to be adopted. This can increase the accessibility and improve the response times from the patients. On similar lines, if the collaboration and communication platform can be made available over mobile devices like smart phones, tablets etc. the patient compliance and response times will improve considerably. Tools like Microsoft SharePoint make it easy to enable the social features and also deliver content to mobile devices.

Conclusion

Overall the ability of a sponsor or CRO organization increases tremendously to virtualize their clinical trial process by leveraging collaboration and content management tools. The overall “Risk-Based” approach to site monitoring and source document verification will also be “made easy” through these tools.  As noted in my previous posts, leveraging a tool like SharePoint for such purpose will improve the Return on Investment (ROI) and reduce the Total Cost of Ownership (TCO) of these tools.

As always, your feedback and comments are welcome.

Update, 20-Mar-2012:

This post has been picked up by www.AppliedClinicalTrialsOnline.com and published on their website.

Impact of Technology on Life Sciences Industry

Recently I was asked to provide inputs to an Article/White paper that looks ahead in terms of Technology and its impact on Life Sciences in medium to long-term. Here’s a list (in no particular order) that I thought would be the key trends to look out for from a short to medium term. I pulled this together based on some predictions by the industry analysts as well as thought leaders along with my personal experiences with some customers and their immediate to medium term requirements.

  1. Mobility: It is a universal fact that the adoption of mobile devices, be it smart phones or tablets, is increasing at a phenomenal rate. This will force the pharmaceutical organizations to adopt a “think mobile” strategy. This trend will mandate the IT and technology teams to adopt an enterprise mobile strategy. In the long run this could even result in applications developed 100% for mobile devices only.
  2. Solutions on Cloud: Adoption of SaaS and Cloud based solutions and services have been increasing over the last 2 to 3 years. Pharmaceutical industry being historically conservative, the rate of adoption is not the same as some of its peer industries. The Sales & Marketing departments within life science companies have been better at this. This will change soon and we will see cloud based solutions adopted in the R&D space as well.
  3. Multi-Device Applications: As the pharmaceutical industry is highly regulated, for obvious reasons, their IT organizations have been seeking higher control on the devices used to access information and data. With the advent of smart phones and tablets and rapid adoption, all new applications developed, by default, will target multiple devices.
  4. Source Data Integration and Business Insights: Life Sciences organizations are realizing the fact that they have been collecting tons of useful data but have not been able to analyze and make smarter decisions using this data. This is leading to more and more programs and initiatives around Master Data Management, Source System Data Integration, and Enterprise Data Warehouses etc. This trend will continue and will even lead to industry wide cooperation and collaboration for the greater good in terms of patient safety, efficacy and outcome based pricing.
  5. Personalized Medicine and Technology Requirements: As the healthcare costs keep rising in countries like US, the scrutiny on the money being spent on drugs, devices and treatments is increasing. Also, the outcomes from usage of the products are being considered as a measure to regulate the pricing of the products. This will lead to more personalized treatment and care for patients based on whether they would be the right candidate for the proposed treatment/intervention. This would drive IT and technology teams to develop solutions for being able to identify the target patients for the products from the patient population.
  6. Standards Based Systems and Integration: Organizations and people cannot exist in silos. They have to continuously communicate and coordinate to make things work. This is the case with IT systems. Most of the legacy systems existing in pharmaceutical industry have been designed and developed to suit the specific needs of customers. In this day and age of continuous information exchanges this poses a big challenge due to the proprietary nature of data. While there are existing standards (from groups like CDISC, HL7, DIA etc.) that have been adopted, there is still need for building systems from the ground up to support these standards. This trend will increase and drive the IT organizations within Pharma as well as vendors developing solutions for Pharma industry to adopt these standards and build them into the tools and applications being developed.
  7. Social Media and Data Complexity: This is another area that has seen tremendous growth in the last 3 to 4 years. However, in the life sciences industry there is lack of guidance and direction from a regulatory stand point. However, this has not stopped the marketing and other customer focused groups embrace this channel of outreach. While this has benefited some customers tremendously, few others got into trouble with the regulators. Organizations that have started collecting the data are sitting on a gold mine of unstructured data. In order to process this data and generate business insights, it requires investments in technology. We will see more and more organizations increasing the adoption of social media but also increasing investments in leveraging the data generated and make strategic business decisions based on the insights thus obtained.
  8. Technology adoption for Emerging Markets: The dynamics in terms of technology adoption in emerging markets is unique and different from developed markets. For example, the adoption of mobile phones is higher than desktops in India. This requires a change in strategy in technology investments for pharmaceutical organizations. Similarly as the global nature of clinical trials increase, the technology available at some of the emerging market study sites is very different from US or EMEA study sites. This will demand a new technology approach to developing and deploying solutions to these markets.
  9. Global Regulations and increasing system complexity: As pharmaceutical customers introduce more and more products in emerging markets, they have to be compliant in terms of process and systems to meet the local regulatory needs. While there would be country/market specific regulations, the systems deployed to manage these processes are usually global in nature. This will increase the need for building systems compliant with multiple market regulatory compliance. For example a New Drug Application (NDA) can be submitted electronically in US and few other countries where as in some emerging countries these are still being submitted in paper form. This requirement will demand a system capable of reusing documents and content for multiple markets by taking the local regulations into consideration.
  10. Self-Assist Devices and Remote Monitoring: As stated earlier, due to increasing healthcare costs patients are trying to avoid hospital or clinical visits to the maximum extent possible. Healthcare and Pharmaceutical organizations are working towards providing devices that can be used by customers without much technical assistance. These devices should be monitored remotely and also data thus collected need to be pushed onto database systems for further analysis. This will pose challenges in terms of not only building easy interfaces to these systems but also ensuring accuracy and security of data.
  11. Healthcare and Pharmaceutical Industry Convergence:  Healthcare organizations like Providers and Payers have gigabytes and petabytes of longitudinal data that can be mined to make more informed decisions about the target patients for certain treatments as well as outcomes of treatments. There are industry initiatives like the Sentinel project to leverage this data. These initiatives will drive industry wise collaboration and integration of systems to exchange information. This will demand existing and new systems to adopt standards for information exchange as well as develop and implement new systems to leverage the information gathered through this collaboration. We will see more and more systems that will cut across those two sectors and help in the convergence.

As always, your feedback and critique is most welcome.

%d bloggers like this: