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Clinical Trial Management With a Digital CRO:

How TEMPO™ Increases Study Efficiency

Deploying the right technology can bring visibility and a level of collaboration and control that is not possible in a traditional CRO environment. That vision is the foundation at Clinipace Worldwide.

Our unified, web-based software platform, TEMPO™, integrates the  spectrum of clinical trial functions, including site selection/management, patient enrollment, project management, monitoring, data management, and biostatistics. The platform is updated in real-time, providing project- and stakeholder-wide visibility of clinical research processes, trial data, and document metadata.

TEMPO is built with configurable modules that can be quickly customized to meet the needs of a particular study or portfolio of studies. Key features include:

  • Study Portal: houses the study protocol, investigators’ brochure, and other documents along with announcements, frequently asked questions (FAQs), and team contact list.
  • Trial Manager: start-up workflows and documents needed for site initiation, including contracts, essential regulatory documents, and institutional review board/ethics committee (IRB/EC) submission status reports are available in real-time.
  • EDC: trial data, including enrollment, electronic case report forms, embedded medical images (based on Digital Imaging and Communications in Medicine [DICOM] standards), source data verification, query management, and trial supply (drug kits, etc.) inventory management.
  • Monitoring & Trip Reports: real-time access to trial data enables risk based monitoring that ties monitoring activity to actual site enrollment, behavior, and clinical data instead of relying exclusively on a date-based site visit schedule. This module also allows clinical research associates (CRAs) to complete trip reports on-site using the same interface, saving time and reducing costs.
  • Safety Management & Reporting: streamlined reporting of adverse events, including workflows for case management and the approval of patient narratives.
  • Trial Master File (eTMF): stores all necessary regulatory documents in compliance with the standards set forth in DIA Reference Model 2.01 and allows CRAs to perform on-site reconciliation of regulatory documents in TEMPO. The platform can also use document metadata alert users when a document approaches its expiration date.

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TEMPO™ eClinical

TEMPO™ eClinical Platform, a private cloud-based application, serves as the technology foundation to all of Clinipace’s clinical development service teams. Through its one platform-one database approach, Clinipace and client study teams leverage TEMPO to improve study visibility, control deliverables and documents, and reduce costs from start-up to close-out. TEMPO replaces the need for multiple disparate technologies such as CTMS, EDC, TMF, Safety, and Portals, which are bolt-on applications that increase trial complexity, cost, and “friction” points between functional groups.

“I’ve been in this industry a long time and this is the first tool I’ve seen with the flexibility we needed to manage our research processes.”

– John Ely, VP, Regulatory Affairs at On-X Life Technologies

Clinipace introduces the concept of Configurable Modules, which are a set of predefined workflows, forms, and reports bundled together as a unit on the same platform within one database. These flexible modules enable study teams to deploy the right set of functionality to support the unique needs of a single study and support more functions without the need for costly data duplication or systems integration.

Published modules include:

  • TEMPO™ Trial Manager
  • TEMPO™ Trial Master File (eTMF)
  • TEMPO™ EDC
  • TEMPO™ Patient Reported Outcomes (ePRO)
  • TEMPO™ Monitoring
  • TEMPO™ Safety Management
  • TEMPO™ Clinical Event Committee (CEC)
  • TEMPO™ Drug Accountability
  • TEMPO™ Medical Imaging
  • TEMPO™ Study Portal

The ability to provide cross-function and cross-trial management and visibility without excessive and expensive IT infrastructure is a huge benefit to clients. Through the TEMPO framework Clinipace can more rapidly deploy innovative services that enhance quality, while creating additional efficiencies that continuously improve study visibility without lengthy development cycles.

Key Platform Features

  • Real-time performance reporting
  • Workflow engine
  • Flexible configuration
  • Embedded medical images
  • Adverse event data collection
  • Data validation
  • Automatic randomization
  • Source data verification (SDV)
  • Query management
  • Investigator/Site payment
  • Inventory management
  • Automated PDF casebook
  • Automated exports (SAS, CSV, XML)
  • 21 CFR Part 11 compliant
  • Audit trail & eSignature
  • Supports CDISC ODM/SDTM

TEMPO Delivers

  • Complete visibility into your study
  • Speeds start-up and saves money
  • Improved investigator relationships
  • Clean data
  • Simple and efficient data collection
  • High user adoption
  • Simplified patient reported data
  • Real-time alerts and notifications
  • Real-time, remote data review
  • Standardized monitoring processes
  • Inline support for protocol information
  • Knowledge of study inventory

Together with TEMPO, Clinipace Worldwide offers data management services that ensure clean, accessible, quality data. Data Management Services are designed to ensure:

  • Data validation and cleansing
  • Quality assurance
  • Database auditing
  • Data reconciliation
  • Export Management

“I was able to significantly reduce the time it would have taken to identify sites and eligible patients by mining the registry data through TEMPO. The collaborative nature of our relationship with Clinipace as well as the flexible workflow processes and real-time reporting enabled the project team to complete the research phase in as little as 7.5 months.  Without the collaboration, a similar project would have taken me 3 years.”

- Andrew Asimos, MD, Director of Emergency Stroke Care Carolinas Medical Center, North Carolina Collaborative Stroke Registry

TEMPO™ Trial Manager

TEMPO™ Trial Manager tracks key study metrics and provides numerous standard reports, as well as powerful performance reporting.

“The eTMF module within TEMPO Trial Manager decreases our workload and provides us {clinical trial administrators} the opportunity to work more efficiently.”

- Cheryl Shorter, Manager, Clinical Trial Administration at Clinipace Worldwide

The transparency that underlies our methods serves to instill confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are/were operationalized in the trial.

The integration of all project meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial. The use of technology thus enhances quality control and project efficiency; but also makes the evidence of these artifacts easily manifest through the use of performance metrics.

The Clinipace Worldwide electronic Trial Master File (eTMF), integrated within TEMPO™ Trial Manager, provides a quality controlled end-to-end process which enables the electronic searching and viewing of TMF documentation and meta-data. All paper or electronic documentation from sponsors, subsidiaries, CROs and field-based personnel is prepared, scanned, described, stored and centralized in TEMPO™ Trial Manager where it is then available for viewing and tracking over the internet. (Once uploaded and stored in TEMPO™ Trial Manager, the actual paper documentation can be filed securely within our approved document filing room.)

The power of eTMF within TEMPO™ Trial Manager is in its secure, permission-based, Web-accessibility so the entire study team can easily locate any document or set of documents required. Searching can be done either within or across studies, sites, document category or type (general section or investigator site files), including the ability to create and run reports that organize essential documents by status, request date, received date, filed date, expiry data, required for IP release, inclusion in end-point adjudication dossier, and more.

eTMF is a powerful and scalable document management solution and a study management tool delivering clinical trial teams with centralized and accessible study documentation for CRAs, Study Managers and others to use in managing activities associated with ensuring a secure, compliant, and complete TMF.

 

Key Features

  • Point-and-click functionality to view, create, edit, move, and/or delete folders and documents
  • Role and permission-based control so only authorized staff can create, edit, move, and/or delete documents and files
  • Ability to create document containers as a placeholder for documents that must be collected in the future
  • Mass update function to easily update key meta-data of one or more documents
  • Complete and comprehensive visibility into to investigator site file to assist with reconciliation between the TMF and site-based regulatory binder
  • Role-based permissioning ensures visibility, while controlling access
  • Universal meta-data management to ensure complete lifecycle management and visibility of all essential TMF documents
  • Integrated TMF and investigator site file completeness reports and ad hoc reporting engine
  • Advanced filtering capabilities to locate essential documents based on sponsor, study, site, category, and/or type
  • TMF integrated study, site, and monitoring visit records within TEMPO™ Trial Manager to enable CRAs to view existing documents and add new documents (trip reports, etc)
  • Ability to export all study-related TMF documents and copy onto a DVD
  • Document versioning and complete audit trail reports

Implementation

The overall timeframe of the configuration process takes between 8 and 12 weeks from content finalization, and it is managed by highly skilled and experienced clinical data managers who possess, on average, 5-7 years of life sciences experience. Clinical data managers lead a team representing the following functions:

  • Engineering
  • Database management
  • Information technology

We take a phased approach to planning, configuring, and deploying the ePRO/EDC solutions. Our seven (7) phases ensure accurate “discovery” and requirements gathering, as well as information sharing and complete transparency with the project teams.

Consistent with our existing processes, we propose the following seven phases, many of which occur concurrently, during our partnerships: 1) Planning; 2) Configuration; 3) Data Migration; 4) Training; 5) Documentation; 6) Deployment (Live); and 7) Production Support.

Specifically, implementations typically follow a well-defined process, as outlined below:

Step 1

Customer and Clinipace Worldwide teams collaborate on creating four specification documents. The data and edit specs are spreadsheet documents and represent the variables [fields], variable type, values, order, and validation rules. The workflow and reporting specs are text documents and represent the inter-relationship between forms, field/form behavior, form flow, branching, and reporting data and layout.

Step 1a

Completing the specs is a collaborative process and the completion time frame is completely dependent on how motivated the customer is in completing the process and their ability to communicate how they want to operationalize the project protocol. Within this collaborative process, the customer owns the “content” of the specs and we work with them to complete the actual specifications in required format, if needed.

Step 2

Once the “content” is completed the configuration of TEMPO™ can begin. Configuration can occur concurrently with spec creation [and we can iterate with the customer], BUT, at a minimum, a draft of the data spec must be complete. The configuration tool transforms the spreadsheet-based data [variables & values] and edits [validation] specs into a CDISC ODM compliant XML file which defines the database schema. The output of this process is an XML file that is CDISC ODM compliant. This step typically takes place during the first 2 weeks after “content” from the specification process is complete [step 1].

Step 3

The Admin tool accesses the CDISC ODM compliant XML file to automatically build out the database and forms. The Admin tool connects to the TEMPO™ infrastructure – reading/writing data to both the database and application server. In addition, workflow processes and rules are configured [we call them “acts”], site & user accounts are created/managed, and reports are defined and built within this tool. Technically, the Admin Tool simply acts as a middleware layer that enables our professional services team to configure and administrate the TEMPO™ platform. Steps 3 through 5 typically occur during weeks 3-12 of the set-up and deployment process.

Step 4

The TEMPO™ environment is built and ready for customer feedback. In the preceding step the database is built, workflows are defined/configured, sites & users are created, and reports are activated.

Step 4a

Based on customer feedback, changes can be made very easy and TEMPO™ can be quickly re-configured. During the iterative process, changes to the forms [variables, layout, values, data validation, etc] are made within our system tools, a new XML file is generated which is then acted upon by the Admin tool. This process continues quickly and is transparent to the customer. The output of this step is a platform that is ready for user acceptance testing [UAT].

Step 4b

If any issues arise during UAT, changes are made and the testing continues until the UAT document is signed. The output of this step is TEMPO™ is released to production [RTP]

Step 5

TEMPO™ is ready for use!

Hosting & Support

The TEMPO™ eClinical Platform is a hosted software solution that is delivered as a service, including all hardware, communications, and software needed to efficiently support a clinical trial and/or registry. The network infrastructure is managed by our highly trained personnel, and is physically hosted at a top-tier data center(s) owned and operated by Windstream. These data centers offer world class physical and logical security, as well as a reliable network operations center for our staff to manage owned hardware and software including redundancy, back-up and recovery systems, which enable our clients to achieve regulatory compliance.

We have access to four SAS 70 Type II certified Data Centers in Boston, MA, Charlotte, NC, and Raleigh, NC (2), providing best-of-breed data center operations with hardened physical infrastructure, security, and environmental services. The Statement on Auditing Standards No. 70 (“SAS 70″) is an internationally recognized auditing standard developed by the American Institute of Certified Public Accountants (AICPA). This certification confirms that a service provider has internal controls that are suitably designed and operating effectively to administer and support mission critical business processes.

The hosted TEMPO™ eClinical Platform has been designed from the ground up to provide the highest levels of audit control, data integrity, access control and security in the industry today. The system architecture and design has been reviewed by independent security consultants to ensure that the system is safe. We provides enterprise-class security features in both our TEMPO™ software as well as hosted services, designed to meet or exceed the exacting standards of healthcare and pharmaceutical research.

Connectivity

Our hosting facility brings fiber into the building from multiple Local Exchange Carriers (LECs). Each LEC provides a “self healing” SONET backbone. These LECs connect to different Tier-1 Internet backbones using Interexchange Carrier Service (IXC). This combination provides you with a multi-homed, redundant network solution. If one fiber path is lost due to construction, LEC or IXC outage, these multiple paths to the Internet will keep you connected.

Additionally, the facility uses redundant OC-3 (155Mbps) fiber from both Cable & Wireless and Sprint. The datacenter’s architecture utilizes Riverstone wire speed Layer 3 routers all the way to the client router, switch, or firewall. Unlike other hosting companies that utilize Layer 2 switches and VLANS, this architecture employs very reliable, secure routers running at gigabit speeds.

Backup & Retention

We have a server backup strategy and retention plan with daily, weekly and monthly rotations to ensure maximum security and backup.

On a daily basis, a full warm backup (an RMAN – recovery manager – backup of the entire database with the database running), full cold backup (a full backup of the entire database file system via custom scripts while the database is off) and archive logs (databases are run in Archive Log mode and a second copy of logs are kept on the backup server) are done on all Oracle database files. An incremental backup is also done on operating system changed files.

On a weekly basis, a full warm backup and full cold backup are conducted on all Oracle database files. A full backup of Operating system files is also done.

On a monthly basis, all Oracle database files have a full warm backup and full cold backup, as well as a full backup of Operating system files.

All Clinipace Worldwide application and web servers are hosted in 3-node Dell R710 VMWare 4.1 ESXi cluster with guest vm’s “living” in a highly redundant EMC Storage Area Network (SAN) at the storage layer. The guest operating systems are all running on a virtual Linux platform which allows us to build or move servers in minutes rather than days. Each TEMPO™ instance and web servers connect to a redundant pair of database servers running Oracle 11G, which is the industry standard database for the management of clinical research data.

All Clinipace Worldwide database servers are on a grandfather-father-son backup rotation which is a full backup each weekend and an incremental backup each weekday. The weekend backups are stored for the remainder of each month, and the last weekend’s full backup is kept on a SAN in Hosted Solutions Charlotte datacenter where all backups are replicated on a weekly basis, thereby insuring an offsite copy is kept in a secure location.

Data Encryption

All data transfers from the browser client to our data center are made using standard 128-bit encryption, the same encryption used for financial and medical data transmission over the Internet.

Technical Support

We offer both standard and premium client support. Our standard offering includes both telephonic and online support to clients and their end-users delivered during business hours [M-F 8am – 8pm EST]. Our premium offering is customized to meet your specific needs. Our data centers are co-located in Raleigh, NC and Charlotte, NC.

Standards & Compliance

Clinical Data Interchange Standards Consortium (CDISC)

We are a proud supportor of CDISC and their work to create and evangelize data standards within clinical research. To this end, TEMPO™ currently supports and complies with the following CDISC standards:

  • Operational Data Model (ODM)
  • Study Data Tabulation Model (SDTM)
  • Study Design Model in XML (SDM-XML)

21 CFR Part 11

TEMPO™ is deployed as part of a validated system that complies with GCP predicate rule requirements, laws, and regulations for clinical trial conduct and FDA 21 CFR 11 for electronic record and signature use.

System Validation & Control

In the process of supporting various types of research initiatives, we must be robust enough to withstand regulatory and client scrutiny. All of our clients benefit from our operational integrity, even patient registries and other projects that may not produce data bound for FDA, NICE, EMEA submissions. This operational integrity results in reliable software, processes, and ultimately – data.

Standard Operating Procedures (SOPs)

Clinipace Worldwide SOPs govern how we manages our business and client data. Formal adoption of, and adherence to, a comprehensive set of SOPs based in part on ISO, COBIT, iEEE standards and FDA regulations ensures consistency and integrity in operations. These SOPs are available for review on site by clients and their designees.

Software Development Life Cycle (SDLC)

SDLC governs how we manage our software products and development processes. The SDLC fully documents the software and installs software version/release controls. All new features and bugs are tracked and triaged using industry standard tools. Documentation includes:

  • Software Design Specifications
  • Software Requirements Specifications
  • Software Functional Specifications
  • Validation Plan
  • Traceability Matrix
  • Installation Qualification
  • Operational Qualification
  • User Acceptance Testing

Quality Control/Quality Assurance

We conduct thorough testing of all software products to ensure functionality is consistent with specifications. Formal test scripts are created according to documentation, and conducted by internal staff as well by the client, or their designee. There are several levels of testing that occur, including:

  • Internal testing of administrative tools on a version basis
  • Internal testing of TEMPO™ platform on a version basis
  • Documentation of testing
  • Resulting in formal validation of the TEMPO™ platform

Once the platform is validated, each project goes through a similar process.

  • Internal testing of client-specific configuration (client project)
  • User acceptance testing of client-specific configuration (client project)
  • Documentation of testing
  • Resulting in release to production of client project

SaaS and Cloud Computing

A scalable, cost effective approach to delivering clinical research services

Traditionally, companies and institutions have been required to buy, build and maintain their own IT infrastructures, incurring great costs in the process and placed in the position to support legacy systems well beyond their utility. Software-as-a service (SaaS) computing provides a better alternative. With the adoption of the web as a computing platform, enterprises and institutions can now plug-in and subscribe to software services whenever they need them, however they need them and for as long as they need them.

TEMPO™’s design is based on the reality of delivering SaaS, and it represents the foundation for on-demand clinical research systems. This approach enables TEMPO™ to rapidly and efficiently deliver the core value of the application — the ability to capture, manage, and share information easily, efficiently and effectively across thousands of investigator sites and among all project stakeholders. This means less complexity and cost for you.

By hosting and maintaining TEMPO™ in our data center, we eliminate the need to invest in dedicated IT staff, hardware and software while ensuring that our clients have immediate access to the latest software updates and upgrades.

Up in the cloud

In its most basic sense, cloud computing generally means “location agnostic”, and there are many clear advantages to using a resource not tied to a single physical location or machine. Benefits of cloud computing include:

  • Load balancing across wide ranging geographic areas
  • More efficient consumption of computing resources
  • Lowered operational costs
  • Increased security
  • Fault tolerance
  • Flexibility
  • Mobility
  • System uptime
  • Disaster recovery

There are ways to leverage the benefits of cloud computing even for heavily regulated industries such as pharma and biotech.  However, the key is taking the time to understand each offering and how it is structured, maintained and protected. Asking yourself the following questions as they apply to different forms of cloud computing will help clarify what option will work best:

  • Can I see it?
  • Can I login to it?
  • Do I control it?

Whether public, private or hybrid cloud, we can help determine which type of cloud computing resource will help your organization reach its goals, while meeting your time, budget and regulatory concerns.