INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

Background and Company Performance Industry Challenges esource: Electronic Clinical Trial Solution Clinical trial sponsors and clinical research organizations are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the Research and Development (R&D) process. R&D budgets for human trials (Phases 1-3) have increased from $13 billion to $40 billion (2001-2010) with clinical trial outsourcing costing close to one-third of the budget. Bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.3 billion, or an average of $146 million per year. Industry data shows that clinical trial costs are growing across all development phases. Across multiple therapeutic areas, per-patient clinical trial costs increased an average of 70% from 2008 to 2013. The largest increases occurred in Phase IIIa and Phase IIIb. Phase I trials are also suffering from cost inflation, with per-patient costs increasing by an average of 46% over the same time period. Clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the United States (US). In fact, recent estimates indicate that within the next three years, up to 65% of studies under Federal Drug Administration (FDA) regulation will be conducted outside of the US. A review of clinicaltrials.gov and of 300 published reports in major medical journals revealed that one-third (157 of 509) of Phase III trials were being conducted entirely outside of the US, with over half the study sites (13,521 of 24,206) located overseas, including many in Eastern Europe and Asia. The ultimate goal is to bring new treatments to market sooner and address unmet patient needs more quickly. An electronic data management strategy can help sponsors and managing clinical research organizations (CROs) achieve this goal. Comprehensive solutions are needed to implement this strategy, and technological advances such as cloud computing, analytics, and data repository solutions help facilitate this implementation easily and cost-effectively. FDA Guidance on Electronic Data in Clinical Investigations The FDA s first guidance for the use of electronic data capturing (EDC) in clinical trials was issued in 1997 with 21 CFR Part 11. Ever since then, to keep up with the ever-evolving electronic data world, the FDA has provided additional guidance to address topics ranging from responsibilities for monitoring, electronic submissions, electronic signatures, and system validation. Even with these amendments and clarifications, widespread adoption of

EDC has taken more than a decade, and complete electronic data submission remains an elusive goal with new draft guidance by FDA issued earlier this year. Despite the challenges, over the last several years the pharmaceutical industry has largely embraced web-based EDC systems as the preferred means for research sites to input, share, and store trial data electronically. However, the widespread adoption of EDC systems has failed to significantly reduce the cost of conducting clinical research, as EDC does nothing to address the most critical step in the data collection process: the initial point of capture with the patient. Because the initial source documentation continues to be done via paper -- whether or not an EDC system is used later in the process -- data collection remains error-prone, time-consuming, and insecure and negatively impacts other related processes, particularly site monitoring and data cleaning activities. The evidence suggests that simply having an EDC system in place is not enough to achieve optimal speed, efficiency and safety/quality. Sponsors need to focus on areas that maximize their EDC investment to decrease timelines and costs associated with conducting clinical trials, creating more return on investment. Recent Regulatory Guidance on Clinical Investigations (2013) In September 2013, after several years of effort, the FDA released final guidance on electronic source (esource) data in clinical investigations; the European Medicines Agency (EMA) previously released its Reflection paper on esource in 2010. These recommendations ensure the reliability, quality, integrity, and traceability of data from the electronic source to the electronic regulatory submission that will need to be considered when sponsors select their data collection systems. Notably, the FDA acknowledges that the industry has been slow to adopt EDC in the past and states that the express purpose of this new guidance is to encourage and promote adoption of electronic source technologies to capture data directly during a subject visit and to remotely review data in real-time. The agency even outlines the expected industry benefits of adopting esource: eliminating unnecessary duplication of data and associated transcription errors. The concept of Source is well-established in the regulatory landscape and has its roots in ICH Good Clinical Practices where it refers to the variety of original documents and data used in a clinical trial. These documents include items like hospital records, clinical and office charts, lab notes, diaries, pharmacy records, X-rays, and even film. esource can also refer to data collected in the trial, such as clinical findings, observations, and evaluations conducted on the patient. With a purpose-built esource platform system design (e.g., comprehensive audit trails, risk based remote monitoring, back-up & disaster recovery), and good clinical report form (CRF) design (e.g., proper data element identifiers, robust use of edit checks, and

electronic prompts for missing or inconsistent data), the goals of reliability, quality, integrity, and traceability mentioned in the 2013 FDA esource Requirements can be achieved. Critically, this requires a focus on the needs of site users beyond what has traditionally been considered by many EDC solutions which tend to only address the needs of data managers for standardized/consistent data. The advantages of esource extend to a number of electronically collected data. In one case study, the newer platform applications of electronic computerized tomography (CT) monitoring have been estimated to eliminate over 70% of possible errors from manual inputting and save nearly 40% on monitoring travel expenses for source verification site visits. These savings will only increase in the coming years due to the increased number of clinical trials conducted in emerging countries. The FDA s esource guidance also clearly complements the agency s final risk-based monitoring guidance (released August 2013) which discusses a move away from Source Data Verification (SDV) where [you re] simply assuring the accuracy of information through audits, on-site visits and other costly measures to a more efficient electronic source data verifications. (Jonathan Helfgott, Office of Compliance [FDA]). Real-time data collection allows esource platforms to conduct risk-based monitoring, which is an approach that is currently being encouraged by the FDA. Additionally, realtime data collection empowers centralized trial monitoring, which can provide insights into clinical trial data at an early stage, when sponsors and researchers can act and have a positive impact on study outcomes. Entrepreneurial Innovation and Customer Impact of Clinical Ink eclinical Solution Clinical Ink, an eclinical solutions provider, has developed the industry s first purpose-built esource solution to capture data electronically at the point of care. SureSource, a mobile data collection platform specialized forclinical trials, dramatically reduces development costs and timelines. The rapid growth of multinational CROs and global trials has created a serious demand for data management solutions and platforms that allow for cloud-based collaboration. SureSource is able to meet those demands. Clinical Ink was founded in 2007 and spent several years developing the SureSource platform. The SureSource platform was first used commercially in 2012. Since that time, the SureSource platform has been used in more than 50 global clinical trials by 3,000+ users to capture data for nearly 15,000 subjects. SureSource is operated on an electronic tablet, which can be Internet-connected or accessed offline. Clinical Ink can have a study build of custom ecrfs, protocols, and study-specific integrations needed for the clinical trial, all pre-loaded onto the tablet within 8 to 12 weeks. SureSource introduces

automation to the clinical trial process by providing a platform that intuitively breaks the procedure down into five primary steps: start, capture, manage, connect, and submit. Start The SureSource study build process is very similar to a standard EDC study build. However, the outputs are paper-like electronic documents that reflect the clinical workflow of research sites. In addition to the required CRF fields in an EDC system, Clinical Ink also builds in data fields and validations related to the ICH GCP guidelines, study-specific compliance metrics, and patient safety that are typically documented in paper. Despite capturing more than twice as much data as in a typical CRF, the Clinical Ink study build process takes no longer than a typical EDC study build. Capture Unlike EDC systems, the SureSource Tablet captures trial data in electronic format duringthe patient visit, and can support a combination of electronic and paper formats. Due to the critical timepoint for data capture during the subject visit the SureSource application is designed to reflect the typical workflow/practices of sites. The tablet gives the clinical investigator the freedom to write the patient s data and any notes directly into the ecrf, eliminating paper and minimizing any source of error and the resulting need for the verification of data. Real-time data validations ensure data is correct as it s captured; and multiple redundant auto-save mechanisms ensure data is never lost; and robust audit trails and privacy permissions ensure data integrity. Manage The SureSource Portal application provides real-time, remote access to esource documents and source data for sponsors, sites, CROs, monitors, and other authorized third parties to dramatically speed overall monitoring and data cleaning processes. The data can be viewed in real-time through dynamic dashboards that allow users to identify open/closed queries, manage adverse events, and track subject completion status. By nearly eliminating SDV, reducing data queries, and minimizing the frequency of monitoring visits, SureSource can greatly impact clinical trial costs and submission times. Connect SureSource can be integrated with many common supporting technologies to further streamline clinical development. Specifically, IVRS system integration permits pushbutton randomization, drug kit assignment, and supply accountability at the site/subject level from directly within SureSource eliminating another error-prone step of inputting subject data into yet another system. Additional integrations with laboratory systems capture physician assessments electronically and eliminate paper copies of laboratory results at the site.

Submit SureSource utilizes a number of export utilities to format data consistent with SDTM submission standards (included derived fields) in a submission-ready format, as well as automatically creating submission-ready subject CRFs with all the appropriate visit and domain-level bookmarking. Typically, these are activities that take place outside the EDC system and incur extra time and cost, but are a natural output of the SureSource platform. The critical difference with SureSource is that the SDTM data transformation occurs in real-time as study data is collected. Conclusion Pharmaceutical companies and CROs now have a significant opportunity to speed up clinical trials by building on a foundation of electronic clinical trial management systems. As long as sponsors and CROs work with eclinical solutions providers (like Clinical Ink) that can demonstrate their continuing adherence to these evolving guidelines, their studies will not only remain in compliance, but will benefit from the significant time and cost savings today s eclinical systems have to offer, giving them better returns on their investment. For an esource platform, SureSource is ideal for every phase of clinical development. Its solution uses the latest technology to make clinical research easier for sites, sponsors, subjects, and regulators. SureSource offers the freedom to work without regard to connectivity, while allowing fast and secure electronic transmission of source documents and data, making it ideal for clinical research in remote locations. Clinical research sites located in 18 countries around the world have used Clinical Ink s SureSource platform. Regulatory acceptance has been positive with the company having been invited to present to the FDA several times, EMA GCP Inspectors Working Group, and successfully passed an MHRA site audit of the platform. Clinical Ink s client and user satisfaction has been extremely positive, with nearly 80% of users saying SureSource positively affected their clinical trial process and would use it again. With its strong overall performance, Clinical Ink has earned Frost & Sullivan s 2014 North American eclinical Solutions Entrepreneurial Company of the Year Award.

Significance of Entrepreneurial Leadership Ultimately, growth in any organization depends upon customers purchasing from your company, and then making the decision to return time and again. In a sense, then, everything is truly about the customer and making those customers happy is the cornerstone of any long-term successful innovation or growth strategy. To achieve these dual goals (customer engagement and growth), an organization must be best-in-class in three key areas: understanding demand, nurturing the brand, differentiating from the competition. This three-fold approach to successful entrepreneurship is explored further below.

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