Conducting clinical trials is a necessary part of product development for the life science manufacturers who need regulatory approval before they can market their products. Thankfully, there is a range of very functional clinical study automation and management applications that are available to help simplify and streamline clinical study activities. During the past three years, adoption of these applications has moved from pilot implementation into full-scale, enterprisewide deployment. Many of the leading-edge life science companies boast that all new development projects are being conducted electronically. The next hurdle for these companies is to perform a detailed examination of their clinical study processes to see how electronically facilitated actions could improve their practices even further.

Life science manufacturers are moving toward an architected platform for clinical study automation and management applications that meet the requirements of the entire enterprise. This MarketScope analyzes the recent performance of the vendors serving the clinical study market that meet the inclusion criteria. Gartner raised the minimum inclusion criteria for the 2007 MarketScope to $10 million in sales revenue in response to clients' requests for information on vendors that could support their enterprisewide requirement for global research. This is a milestone when the company has moved out of the startup stage and is able to sustain a revenue stream that supports geographic expansion and a continued investment in R&D. The MarketScope rates each vendor based on Gartner's vendor-rating definitions. It also provides an overall market rating using the same definitions.

Clinical study applications have been evolving from data-centric applications to Web-based offerings that facilitate the wide range of transactions that occur during clinical trials. The products on the market today are designed for users that are familiar with user-friendly, Web-based applications, such as Amazon and Google. They follow a role-based paradigm that gives users access to only the information they are entitled to see or change. Applications routinely provide users with navigation aids, intelligent forms, hyperlinking, automatic in-line error checking (both hard and soft) and embedded calculations. Robust electronic information capture has ceased to be a differentiator; instead, users want fast, flexible and integrated platforms for conducting clinical study.

With so many trials being conducted in multiple geographic locations, compliance with global industry standards for clinical research (for example, good clinical practice guidelines) is a given. Applications also adhere to specific regulations, such as the U.S. Food and Drug Administration's (FDA's) regulation on electronic records and signatures (21 CFR Part 11). Increasingly, vendors are adding support for Clinical Data Interchange Standards Consortium (CDISC) standard data structures and terminology as the industry recognizes the positive impact of standardized clinical study data.

The set of improvements to applications for clinical development will be delivered by vendors that employ a service-oriented architecture approach to create a robust clinical study platform. Some key requirements of this expanded platform are:

• The availability of services to perform often-repeated functions and to automate those requiring human intervention
• Reliance on industry standards that facilitate the integration and exchange of clinical study data
• A shift from paper-based information collection to electronic source data (eSource), in which information is captured initially into an electronic record
• Information aggregation to enhance real-time analysis, facilitate safety signal detection, improve data-mining capability and facilitate adaptive clinical trials
• A capability to integrate and process a wide variety of information formats, including audio and visual images
• Cross-functional and cross-organizational workflow management
• Simplified integration with related systems, such as clinical supply production and electronic medical records
• Incorporation of new devices and technologies, such as radio frequency identification (RFID)
• Collaboration tools to make all participants in clinical study activities more productive and effective
• Multilingual product and help desk support for global clinical research
• Real-time alerts and notifications in and out of clinical study systems

In "Clinical Study Automation and Management Applications Market Definition, 2007," Gartner identified five stages of clinical study:

• Study design is the stage at which the study plan, protocol and procedures for program implementation are developed. The protocol describes the objectives, design, methodology, statistical considerations and organization of a clinical study, including determining what types of subjects may participate in the trial, the schedule of tests, procedures, medications and dosages, as well as the length of the study. Study design provides tools to simulate and test the various study scenarios.
• Study setup and operation includes the activities required to recruit clinical investigators, to recruit and enroll study subjects, to prepare data collection tools (for example, case report forms [CRFs] and electronic case report forms [eCRFs], databases and documentation), to ensure that an adequate supply of product will be available to be tested, and to create a process for monitoring and tracking study progress that adheres to regulations. Study setup may also include development of a collaboration environment for study teams.
• Information collection and management spans the process of data collection through to database lock, whether data is obtained manually or by using electronic information capture tools, such as electronic data capture (EDC) and devices such as electronic patient diaries (EPDs) that capture electronic patient-recorded outcomes (ePROs). It includes collection and data entry into the database, checking collected information for errors and resolving them, monitoring processes, and being on the alert for adverse events.
• Study data analysis covers the statistical analyses and production of tables and graphs that enable the clinicians to interpret the study findings. Typically, this analysis step occurred after database lock, but as life science manufacturers shift the research paradigm from a series of sequential stages into a set of parallel processes, efficacy and safety analysis occurs coincident with information collection and management.
• Regulatory submission is the stage at which the application for approval to market the product is created, reviewed, approved, formatted by the study sponsor and submitted to the regulatory authority by its preferred means.

Vendors are beginning to provide a comprehensive solution that spans all five stages of clinical study. However, the vendors included in this MarketScope are primarily focused on providing applications that support the first four stages of clinical research from study design to analysis and reporting. Vendors will often categorize their applications into three groupings, based on technology orientation: electronic information capture (EIC), which includes EDC and ePRO; clinical trial management systems (CTMSs); and clinical data management systems (CDMSs).

As life science companies evaluate the solutions available from various vendors, they should consider their functionality requirements, clinical study profiles and risk tolerances. The vendors that are included in this report are all capable of supporting Phase I-IV trials that are being conducted on a global basis.

Figure 1 is a graphical depiction of the vendor offerings arranged by product coverage across the stages of clinical study and ordered by the vendors' organizational footprint. The organizational footprint is a gauge of the vendor's size, using a combination of revenue derived from the sales of clinical study applications and number of employees involved in clinical study application development, maintenance and support. This view allows Gartner to position the vendors without revealing confidential financial information from the firms that are privately held.

The product coverage assessment was created using the responses provided in the vendor survey questionnaire, the information obtained during the demo and briefing, and input from client reference checks. The chart intends to convey categories of functionality provided by the vendor and currently being used by customers. It does not measure how well each category is supported by product features. It indicates the product offerings sold directly by each vendor and does not portray functionality that may be provided through an alliance partnership. Filled circles indicate the vendor provides extensive functionality, doughnuts indicate moderate functionality, and open circles indicate some functionality exists or is soon to be released. No circle indicates functionality not provided by this vendor.

To be considered for this MarketScope, each vendor of clinical study automation and management solutions must meet the following criteria:

• It must have as its primary business the development and maintenance of commercially available software applications, and it must provide applications for the automation and management of clinical study of human health products.
• Its products must provide functionality for at least two of the following three capabilities:
  • Clinical study data collection
  • Clinical study data management
  • Clinical study data and operational data analysis
• It must earn revenue from clinical study applications of at least $10 million. This includes software license revenue, maintenance and related services.
• Its products must have been generally available for at least three years.
• It must support clinical trials on at least two of the following continents: North America, Europe and Asia.
• Secondary research must confirm that it is a significant or an emerging player in the market.
• Gartner's Life Science Member Advisory Board and client inquiry must validate it as a vendor of interest.
• It must provide users with training and help desk support.
• It must offer analytics and reporting across the functional footprint.
• It must be compliant with current regulations covering the conduct of clinical study.

Overall Market Rating: Promising

Gartner's outlook for life science manufacturers investing in applications that provide clinical study automation and management is promising. The market for applications that automate and manage clinical research is large and growing. An increase in targeted treatments and eventually personalized medicine is expected to significantly increase the complexity of clinical study. More trials will be conducted, although there will be fewer subjects per trial. Clinical study applications will need to advance functionality that supports smaller, shorter trials that adapt more quickly based on study results.

Implementation of clinical study applications is on the rise as an increasing number of vendors provide user-friendly products that offer functions to meet key requirements as defined in "Clinical Study Automation and Management Applications Market Definition, 2007." Pressure to rein in clinical study costs has not abated, and this has led to more investment in solutions that can increase revenue and profitability by getting treatments on the market more quickly. The vendors reviewed for this MarketScope all report increased year-over-year sales, typically 15% to 20% but as much as 100%.

Other factors that contribute to our "Promising" rating include:

• The variety of offerings and the breadth of functionality available to users
• The option of several hosted solutions for those companies that do not want to purchase and maintain an application in-house
• The encouragement of regulators to use technology and standardized data in clinical study

The clinical study application market remains a "stand-alone market" with many vendors that offer products unique to clinical research. Of the vendors evaluated in this MarketScope, only Oracle and SAS earn the majority of their revenue from products and services unrelated to clinical study activities. Even though the barriers to entry in this segment are high, because of the unique regulatory requirements of clinical study, vendors that have traditionally not been "players" in the market are eyeing it with interest. Therefore, the clinical study incumbents can expect pressure on multiple fronts:

• Product life cycle management (PLM) vendors are interested in this space because of its potential for steady growth and the obvious need to connect development with other applications used for product manufacturing, marketing and sales.
• Computer-based patient record (CPR) vendors see the potential to improve clinical research by automating the transfer of information from an electronic medical record to and EDC applications and may choose to go after the clinical research market to complement their third-generation capabilities in clinical care.
• Enterprise platform vendors, such as SAP and Microsoft, hoping to expand their footprint in life science companies will use partnerships to create integrated offerings for clinical study.

These factors open the clinical study market to severe disruption during the next few years, as cash-rich vendors make their acquisitions and smaller players merge in an attempt to achieve economies of scale. The ePRO vendors, CRF, invivodata and PHT remain potential takeover targets because of the highly specialized technology they provide. Gartner expects market consolidation to continue as vendors build out solutions that cover all five stages of clinical study.

Almac provides technology and services for clinical study through its Clinical Technologies division. It has a suite of offerings, including iTrial EDC and iDiary for electronic information capture, as well as IXRS for clinical materials, patient and study management via the phone and Web. It provides Study Builder to support sponsors during study design in iTrial EDC and Central Site for administering access to iTrial EDC. Users can enter and review data both online and offline. A recently added feature allows users to click through to the exact form they were working on when they last were in the system. As Almac develops its product suite, it should look for ways to enhance the IVRS and query management functions. Almac's products are built on a technology platform that has a database and transaction layer that users can access through phone, Web or Web devices, such as PDAs or tablets. Almac ensures the availability of the data by maintaining three mirrored copies of study information. Almac's integrated reports allows users to build ad hoc reports using Business Objects' Crystal Reports XI and export reports to a variety of different formats. Once a report is constructed, it will automatically be kept up-to-date as the trial progresses. Almac also lets users create one PDF file per study subject that provides an aggregated view of all data from its iTrial EDC product. Almac provides its products using a software as a service (SaaS) model. Almac is privately held.

Rating: Positive

ClinPhone is best known for providing tools for subject enrollment, randomization, clinical supply management and ePRO. In 2003, ClinPhone acquired the TrialWorks CTMS application. It released a Web-based version of the study management application during 2006. Since its acquisition of DataLabs in 2006, it has increased the product footprint to include electronic information capture and data management. Users appreciate ClinPhone's capability to handle "hybrid" trials that include EDC and paper CRFs by providing tools for double data entry of paper (including conflict and query resolution), CRF tracking and workflow management. During the past year, ClinPhone introduced new products such as ClinPhone Drug Accountability — a Web tool that allows site and sponsor personnel to track clinical supplies from production to patient dispensation, return of used/unused medication, verification and reconciliation of site accountability and return logs, and destruction of study materials. ClinPhone Connect integrates clinical data across the ClinPhone product suite. ClinPhone Connect manages and tracks the movement of information among ClinPhone applications, and between ClinPhone applications and external systems such as Cerner Galt's dsNavigator for dictionary coding and management. Users gain access to ClinPhone's EDC, IVR and CTMS applications through single sign-on to the Connect Web portal. ClinPhone's products have been certified for CDISC ODM and SDTM. As ClinPhone builds out its product suite, it will want to improve the functionality of the drug accountability and trial supply management modules and to continue its investments to integrate its solutions. ClinPhone is a public company (LSE: CNP.L) with $86 million in revenue and 737 employees.

Rating: Positive

CRF provides solutions for electronic information collection from subjects participating in clinical trials. The five components of CRF's solution are integrated under the TrialMax platform: TrialStudio for the design of EPD program, TrialCollector for data collection via wireless or landline devices, TrialManager for monitoring study status, TrialIntegrator for transferring EPD data to other clinical study systems, and TrialEngine for managing study workflow. CRF also offers iPrompt, an SMS-based system for reminders, compliance management and safety surveillance. iPrompt has been used in Europe and is now being used in the U.S. for a post-approval program run by a trial sponsor. During the past year, CRF has added new functionality to its offerings. It now allows users to do their own offline development of screens and localization with TrialStudio Designer. The Web portal in TrialManager lets users check study status in real time through standard or customized reports. It also supports electronic query management. In addition to being supported on Palm devices, TrialCollector is being piloted for Windows mobile and is expected to go into production by the end of the year. This will increase the number of fonts available, allow the use of color images and improve screen resolution. First-line help desk support for CRF's devices is provided by TechTeam. Based on the topic, calls can be escalated directly to CRF or to the trial sponsor. As CRF develops its product set, it will want to consider adding support for devices other than the Palm, improving device quality control and better training for help desk personnel. CRF is privately held.

Rating: Promising

Datatrak International has just released a new version of its product — eClinical Version 4.0, which includes a number of upgrades to previous functionality. Using the Visual Designer or Data Architect design tools along with Trial Manager, users can create and test forms commonly used in clinical study (for example, eCRFs, adverse events, registration) and establish workflows. Pre-existing components can be dragged and dropped to a new form, while various options for modifying the components are suggested on the screen at the same time. It is also possible to select and load trials, roles and permissions, forms, and questions from a library. Other changes in V4.0 include core-lab ECG and image capture, automated validation and reporting as well as standard exports to text, Excel, SAS and PDF. The PDF data in the export file can create an eSubmission in the format required by the FDA. The Data Genie function lets users create ad hoc reports by selecting specific criteria of interest. eClinical supports multiple coding dictionaries and lets users search for similar terms. The application can import drug shipment information as well as monitor and manage drug inventory. Trial Manager provides an executive console with Gantt charts to measure performance metrics in and across studies. As Datatrak looks for ways to enhance its products, it should consider automating functions that currently require custom programming and improving user administration. Datatrak's products are built on a single, unified platform and delivered via a transaction-based application service provider (ASP) model. During the past year, Datatrak invested in the infrastructure required to support existing studies and scale up as volume increases. Datatrak (NASDAQ: DATA) is a public company that employs 110 people and had sales revenue of $17.7 million for the fiscal year ending 31 December 2006.

Rating: Promising

In June 2007, eResearchTechnology introduced a redesigned platform for its clinical study applications that has been rebranded as EXPeRT eClinical. This portfolio of products replaces the eResNet suite. Users access various modules for functions such as data capture and management, site monitoring, and adverse event reporting through the EXPeRT Portal. The development environment allows users to access a library of objects that can be used to create the various documents required for clinical study. The system ships with EDC Now, which maps to CDISC ODM. Developers can import metadata to create forms and export information to CDISC SDTM or other applications that accept data in the CDISC ODM format. During 2007, eResearchTechnology entered a strategic relationship with Healthcare Technology Systems, which gives them an exclusive license to 57 interactive voice response (IVR) cognitive function assessments and consulting services. Study subjects use EXPeRT ePRO — an IVR-based system — to enter their clinical assessment data via a toll-free phone number. Clinical study data is stored in a clinical trial data repository that has been designed using a common data model. Through the zero-footprint portal, users can review embedded reports included with the system. Reports can include graphics that are updated automatically as study data changes. Integration with Oracle Discoverer is also supported. eResearchTechnology provides its products via a license or a hosted solution. Customers currently on a 4.x version of eResNet will have a direct migration to EXPeRT eClinical. eResearchTechnology (NASDAQ: ERES) is a publicly held company that employs 365 people and had sales revenue of $93 million for the fiscal year ending 31 December 2006.

Rating: Promising

Recently, etrials introduced EDC version 2.0, which provides users with a configurable, integrated platform for the collection and management of trial data and study management. Patient interaction data and randomization information can be uploaded into etrials EDC from etrials eDiary, IVR or IWR applications. Multiple eDiary input devices are supported, including handhelds, tablets and laptops. A partnership with Roche simplifies the transmission of vital glucose meter data into eDiary, using infrared or Bluetooth technology. Lab data and images can also be transmitted into etrials edc. Safety information can be exported to Relsys' safety database. Etrials supports multiple export file types such as Excel, SAS, PDF and CDISC ODM and SDTM. It supports medical coding with both industry (COSTART, MedDRA, and ICD) and customer-specific dictionaries. Users can opt to get study status information via standard reports, or they have the option of creating customized reports. Also included in the new release is an online training portal through which users can access product information. Etrials experienced some management turnover during 2007 with the departure of co-founder John Cline, which had a negative impact on gross margin. Nonetheless, the company saw an increase in new project bookings and expects modest growth in year-over-year net service revenue. Etrials (NASDAQ: ETWC) is a publicly traded company that employs 140 people and had sales revenue of $19.2 million for the fiscal year ending 31 December 2006.

Rating: Positive

Solutions from invivodata enable electronic information collection from subjects participating in clinical trials. Study data is collected at the clinic using SitePRO or remotely from study subjects using DiaryPRO. Subjects put the PDA data collection device into a model cradle at the end of the day that automatically uploads data to the server and charges the device. An invivodata ePRO management system enables status monitoring of sites, studies and subjects. Real-time study status information is presented to study sponsors, CRAs, and clinical research coordinators via a dashboard. They can peruse information contained in standard reports, or invivodata can configure reports based on the needs of the trial sponsor. The EasyCharge site device charger simplifies the sites' process of storing and provisioning devices to subjects. Devices have large buttons for easier navigation from screen to screen and can be used in portrait or landscape mode. Data collected with DiaryPRO can be transmitted into Medidata Rave using a CDISC ODM compliant integration link that eliminates the need for custom coding. Data can also be exported to Excel. Invivodata is privately held.

Rating: Promising

Medidata Solutions Worldwide's current product for clinical study is Medidata Rave 5.6, which was introduced earlier this year. Some of the new functionality includes a global library, improved handling of CRF attachments and the ability to localize reports. The global library wizard presents all the base forms that would be used for the study protocol and makes them available for reuse. A permission-based security model determines access and user privileges. A variety of file types can be appended to the CRF such as images (for example, X-rays) and documents (for example, death certificates). The system comes with 27 standard reports. Additional ad hoc analytics capability is provided by Business Objects and JReview. The paradigm Medidata employs for its offering is the eClinical backbone that emphasizes the transactional nature of clinical study. This metadata-driven approach to information management gives users access to Medidata's clinical study tools (information capture, data and study management, and reporting) and enables the integration of customer-selected applications. Medidata Rave supports CDISC ODM, supports CDISC Lab through a pre-processor and will support CDISC STDM in the next release. Medidata has expanded its clinical study footprint during the past year, through a judicious selection of partners. In June, it announced the integration of Medidata Rave with SAS Drug Development. Earlier in the year, it announced a standard integration link between its product and invivodata's DiaryPRO. This complements relationships with Fast Track Systems for trial design, United BioSource Corporation and Tessella. As Medidata develops its plans for coming year, it needs to work on improving customer service and increasing product stability. Medidata is privately held.

Rating: Positive

Oracle provides a set of components for clinical study, including Oracle Clinical Data Management System, Oracle Remote Data Capture (RDC), Oracle Adverse Event Reporting System (AERS) and Siebel Clinical Trial Management System (CTMS). Oracle RDC is built on the same data model as Oracle Clinical, and both products use the same data entry screens and edit checks. Mixed-mode trials are supported because data entered through RDC is stored in the same tables as data entered through Oracle Clinical. Clinical study data from labs or entered electronically by study subjects is loaded into the database via a batch load, because Oracle currently does not support data capture from EPDs or other ePRO devices. Oracle AERS lets trial sponsors capture, manage, report and analyze serious adverse event and product complaint information. The most recent release of Oracle AERS 4.6 has been internationalized for the Japanese market. Oracle also offers a Siebel Contact Center integration pack for AERS. Siebel CTMS stores operational data and allows study sponsors, site personnel and monitors to perform a variety of trial management activities. They can review study information, monitor subject enrollment, manage site interactions, track study documents, verify study activities and initiate site payments. Oracle Thesaurus Management System (TMS) provides terminology services for Oracle RDC, Clinical and AERS. Oracle Life Sciences Data Hub (LSH) integrates clinical and nonclinical data, making it available for analysis, visualization and reporting. Support for CDISC SDTM and ODM is provided via the LSH. While Oracle has improved the integration among the components of its clinical study suite, there is still room for further simplification. Oracle stated that the latest release of RDC will be an HTML version available for general release in 12 months. Oracle is a public company (NASDAQ: ORCL). However it does not break out its revenue from life science applications.

Rating: Positive

Phase Forward has put considerable effort into developing a user-friendly front-end portal employing SharePoint that links to various modules, such as InForm, Clintrace, Clinical Trials Signal Detection (CTSD) and WebSDM. The most recent release, InForm ITM 4.6, provides improved navigation and workflow that will allow users to speed study operations and reuse components. Central Designer guides study and project managers through the process of outlining the major activities in a study and linking the activities to the data collection forms. Users search and retrieve components, grouping components and forms from a library. To ensure the quality of items placed in the library, only users with the correct privileges can add to the library. The reporting module provides a set of standard reports and also allows users to generate ad hoc reports. Clintrace is the core module for collecting and reporting on safety information. This can be performed during clinical study as well as post-approval. The FDA is using the WebSDM module to review clinical study data. Users with WebSDM can review their data to ensure that it complies with CDISC SDTM and then export the data to the agency. When both the trial sponsor and the FDA are using WebSDM, it simplifies the process of responding to inquiries on the data submitted. CTSD is used for early identification of potential safety signals in clinical trials. A visual map quickly shows adverse events, whether attributed to the drug under study or not. To get more information, the user can click through to the source data used to create the map. Phase Forward offers users a sophisticated set of functionality, but it should continue to address issues of complexity by increasing integration. Phase Forward is a public company (NASDAQ: PFWD) that employs 450 people and had sales revenue of $106.6 million for the fiscal year ending 31 December 2006.

Rating: Positive

Phoenix Data Systems provisions technology and services designed to help sites collect clinical study data and integrate that information into other clinical systems. Phoenix Data Systems' products for electronic information capture — PDS Express and PDS IVR — are delivered via an ASP model. The current version of PDS Express, version 4.0, was released in June 2006. PDS AutoEncoder, which is included as part of PDS Express, supports standard- and custom-coding dictionaries for adverse events and concomitant medications. PDS IVR supports randomization, enrollment tracking and drug inventory management, as well as allowing subjects to input data using a phone. PDS Express and IVR post information to a single database so there is no need for data reconciliation. Information on study performance and metrics is collected in real time from PDS Express and presented via the PDS Reportal. The technology platform that powers the PDS Reportal was recently updated. Standard reports are provided as well as the ability for users to create their own "ad hoc" reports, graphs and charts, which offers the ability to have unlimited customized summary and data reports. Phoenix Data Systems offers services to allow data import from labs, ECG and EPDs and data export to Word, Excel, SAS and CDISC. It is contributing to the CDASH initiative and is working on a library of pre-built CRFs based on "harmonized" versions as they are released by CDASH. It also performs site assessments and assists with study startup, eCRF creation and data management. Phoenix Data Systems is privately held.

Rating: Positive

PHT provides solutions for electronic information collection from subjects participating in clinical trials. PHT's product suite includes LogPad for capturing patient data via a diary, StudyPad for capturing patient-recorded outcomes at an investigative site, and StudyWorks, which presents study data to an online portal. Users develop the diary application using ePRO Designer. Study data is archived in a searchable XML format in the Study Archive. Information from measuring device sensors — such as blood glucose meters — is sent to LogPad using eSense via Bluetooth, wireless, infrared and ZigBee. Data from LogPads or StudyPads can be transmitted using analog or wireless transmission options managed by SimpleSend. PHT staffs its own help desk 24 hours per weekday and has support people on call during weekends. The support staff can handle inquiries in six standard languages and have translation services available for other languages. PHT recently added the capability to generate an e-mail or phone alert to caregivers or trial sponsors when a study subject enters a specified value. PHT also supports individual access codes that can easily be reset in the field when the subjects respond properly to their secret questions. PHT has created custom integration programs for many of the commonly used EDC and CTMS systems. It also supports application integration using CDISC ODM. As PHT enhances its products, it will want to consider providing color on the LogPad. PHT is privately held.

Rating: Promising

SAS Institute is known for providing sophisticated analysis tools. Its offering for clinical study — SAS Drug Development — leverages the capabilities of the SAS9 Intelligence Platform to provide users with a centralized repository of clinical study data that can be mined to extract information necessary for activities such as preparing regulatory submissions, monitoring product safety or exploring new market opportunities. In 2007, SAS added programmer productivity tools for code development, execution and job scheduling. It also added support for multiple languages often required for global implementations and improved performance. SAS Drug Development is used in conjunction with SAS Data Integration, the tool that standardizes, manipulates and loads data from other applications. Clinical study data can be transformed into a proprietary format required by the trial sponsor or, with optional professional services assistance, into CDISC standard models. As SAS builds out its solutions for clinical study, they intend to make SAS Drug Development into a process-driven collaboration environment for scientific data, analytics and reporting that will appeal to a range of users with a variety of analysis requirements and different levels of programming dexterity. SAS maintains a network of relationships with clinical study vendors that offer complementary solutions for electronic information capture and study management, as well as vendors that have products for medical coding, data review and publishing. SAS Drug Development is provided as a stand-alone or hosted solution. SAS is privately held.

Rating: Positive