IBM Study Advance expedites efficiency for the study protocol authoring team by merging real-world patient population data with a guided protocol template within a centralized collaborative workspace

IBM United States Software Announcement 219-379
November 19, 2019

Table of contents
OverviewOverviewTechnical informationTechnical information
Key requirementsKey requirementsOrdering informationOrdering information
Planned availability datePlanned availability dateTerms and conditionsTerms and conditions
DescriptionDescriptionPricesPrices
Program numberProgram numberOrder nowOrder now
PublicationsPublications


At a glance

Top rule

Lack of data and insights early in the protocol development process result in protocols and trial criteria that do not match the real-world patient population. This mismatch impacts the trial during the recruitment process and delays trial timelines. Eighty percent of trials experience delays in recruiting. The cost of delay can be up to $1 million (USD) a day.

IBM® Study Advance can help:

  • Reduce the average time required to author a clinical trial protocol by delivering process and collaboration capabilities
  • Reduce the number of protocol amendments needed during clinical trials by providing unparalleled insights during protocol authoring
  • Increase confidence in protocol decisions by offering immediate access to real-world data about patient populations


Back to topBack to top

Overview

Top rule

Study Advance is a data-driven, authoring tool that targets study protocol optimization by merging both real-world patient population data and standardized protocol template guidance through a collaborative workspace designed to facilitate efficiency. Optimized protocols increase the likelihood of clinical trial success, and reduce the costs tied to protocol amendments, patient recruitment, cycle time, and nonessential procedures.

Study Advance can help manage collaboration through:

  • Structure of protocol elements, such as the template to create a synopsis and using that content to automatically generate a protocol template
  • Project management capabilities to support, for example, multiple authors, assigning team members to sections, setting due dates, accepting or rejecting comments
  • Build, edit, review, and approve protocol elements that track changes to maintain audit trail
  • Notifications for user review and action
  • Ability to understand rationale and supporting data behind study criteria, for example, study participants

Study Advance can help incorporate evidence-based suggestions through:

  • Integration of IBM MarketScan Commercial and Medicare Supplemental databases
  • Eligible participant population cohort building by experimenting with inclusion and exclusion criteria


Back to topBack to top

Key requirements

Top rule

Workstation and browser that support an internet connection to the service.



Back to topBack to top

Planned availability date

Top rule

November 22, 2019



Back to topBack to top

Description

Top rule

Accessibility by people with disabilities

A US Section 508 Accessibility Compliance Report containing details on accessibility compliance can be found on the Product accessibility information website.



Back to topBack to top

Program number

Top rule

Program number VRM Program name
5900-A70 Cloud Service IBM Study Advance


Back to topBack to top

Offering Information

Top rule

Product information is available on the IBM Offering Information website.

More information is also available on the Passport Advantage® and Passport Advantage Express® website.



Back to topBack to top

Publications

Top rule

Not applicable.



Back to topBack to top

Services

Top rule

Software Services

IBM Software Services has the breadth, depth, and reach to manage your services needs. You can leverage the deep technical skills of the lab-based software services team and the business consulting, project management, and infrastructure expertise of the IBM Global Services team. IBM provides the global reach, intellectual capital, industry insight, and technology leadership to support a wide range of critical business needs.

To learn more about IBM Software Services, contact your Lab Services Sales or Delivery Leader.



Back to topBack to top

Technical information

Top rule

Specified operating environment

Hardware requirements

Workstation that supports a connection to the service.

Software requirements

Browser that supports a connection to the service.

The IBM Support Community

The IBM Support Community is your gateway to technical support tools and resources that are designed to help you save time and simplify support. Support Community tools can help you find answers to questions, download fixes, troubleshoot, automate data collection, submit and track problems, and build skills.

You can also access the Service requests and PMRs tool for more support.

Planning information

Packaging

This offering is accessed through the internet. There is no physical media or electronic deliverable.

Security, auditability, and control

Study Advance uses the security and auditability features of the host software.

The client is responsible for evaluation, selection, and implementation of security features, administrative procedures, and appropriate controls in application systems and communication facilities.



Back to topBack to top

Ordering information

Top rule

For ordering information, consult your IBM representative or go to the Passport Advantage website.

This product is only available through Passport Advantage. It is not available as shrinkwrap.


Passport Advantage

IBM Study Advance (5900-A70)

IBM Study Advance introduces the following part numbers:

Part description Part number
IBM Study Advance Participant Insights Instance per Month D0207ZX
IBM Study Advance MarketScan User Instance per Month D0205ZX
IBM Study Advance MarketScan User Item Set Up D0206ZX
IBM Study Advance Instance per Month D0203ZX
IBM Study Advance Item Set Up D0204ZX
IBM Study Advance Participant Insights MarketScan User Instance per Month D020QZX

Charge metric

Definitions of the charge metric for this cloud service can be found in the following Service Description document:

Program identifier Service Description document title Service Description document number
5900-A70 IBM Study Advance 8676-01

Select your language of choice and scroll down to the Charge Metrics section.

Follow-on levels of this cloud service, if any, may have updated charge metrics. See the Cloud Services terms website. Search using the four-digit base Service Description number and scroll down to the Charge Metric section.



Back to topBack to top

Terms and conditions

Top rule

The information provided in this announcement letter is for reference and convenience purposes only. The terms and conditions that govern any transaction for the acquisition of Cloud Services from IBM consist of either the IBM Cloud Services Agreement and the applicable offering Service Description or the IBM International Passport Advantage Agreement or the International Passport Advantage Express Agreement and the IBM Terms of Use - General Terms for Cloud Offerings and the applicable offering Service Description.

Technical support

Technical support is provided for Cloud Services and enabling software, as applicable, during the subscription period. Any enhancements, updates, and other materials provided by IBM as part of any such technical support are considered to be part of the Cloud Service, as applicable, and therefore governed by the applicable agreement as defined in Client's quote or transaction document. Technical support is included with the Cloud Service and is not available as a separate offering.

Additional technical support information for this Cloud Service offering may be found in the IBM Support Guide or in service-specific documentation.

Service Description

The following Service Description document applies to the offering in this announcement.

Program identifier Service Description document title Service Description document number
5900-A70 IBM Study Advance 8676-01

Follow-on levels of this cloud service, if any, may have updated terms. See the Cloud Services terms website and search using the four-digit base Service Description number.

Limited warranty

See the warranty defined in the applicable agreement governing client's acquisition for this offering.

Money-back guarantee

No

Volume orders (IVO)

No

Passport Advantage applies

Yes, information is available on the Passport Advantage and Passport Advantage Express website.

Usage restrictions

Yes. See Service Description 8676-01 for details about this offering.

Follow-on levels of this cloud service, if any, may have updated terms. See the Cloud Services terms website and search using the four-digit base Service Description number.

Educational allowance available

No.



Back to topBack to top

Statement of good security practices

Top rule

IT system security involves protecting systems and information through intrusion prevention, detection, and response to improper access from within and outside your enterprise. Improper access can result in information being altered, destroyed, or misappropriated or can result in misuse of your systems to attack others. Without a comprehensive approach to security, no IT system or product should be considered completely secure and no single product or security measure can be completely effective in preventing improper access. IBM systems and products are designed to be part of a regulatory compliant, comprehensive security approach, which will necessarily involve additional operational procedures, and may require other systems, products, or services to be most effective.

Important: IBM does not warrant that any systems, products, or services are immune from, or will make your enterprise immune from, the malicious or illegal conduct of any party.



Back to topBack to top

Prices

Top rule

For additional information and current prices, contact your local IBM representative.


Passport Advantage

For Passport Advantage information and charges, contact your IBM representative. Additional information is also available on the Passport Advantage and Passport Advantage Express website.

IBM Global Financing

IBM Global Financing offers competitive financing to credit-qualified clients to assist them in acquiring IT solutions. Offerings include financing for IT acquisition, including hardware, software, and services, from both IBM and other manufacturers or vendors. Offerings (for all client segments: small, medium, and large enterprise), rates, terms, and availability can vary by country. Contact your local IBM Global Financing organization or go to the IBM Global Financing website for more information.

IBM Global Financing offerings are provided through IBM Credit LLC in the United States, and other IBM subsidiaries and divisions worldwide to qualified commercial and government clients. Rates are based on a client's credit rating, financing terms, offering type, equipment type, and options, and may vary by country. Other restrictions may apply. Rates and offerings are subject to change, extension, or withdrawal without notice.

Financing from IBM Global Financing helps you preserve cash and credit lines, enables more technology acquisition within current budget limits, can help accelerate implementation of economically attractive new technologies, offers payment and term flexibility, and can help match project costs to projected benefits. Financing is available worldwide for credit-qualified clients.



Back to topBack to top

Order now

Top rule

To order, contact the IBM Digital Sales Center, your local IBM representative, or your IBM Business Partner. To identify your local IBM representative or IBM Business Partner, call 800-IBM-4YOU (426-4968). For more information, contact the IBM Digital Sales Center.

Phone: 800-IBM-CALL (426-2255)

Fax: 800-2IBM-FAX (242-6329)

For IBM representative: askibm@ca.ibm.com

For IBM Business Partner: pwcs@us.ibm.com

IBM Digital Sales Offices
1177 S Belt Line Rd
Coppell, TX 75019-4642, US

The IBM Digital Sales Center, our national direct marketing organization, can add your name to the mailing list for catalogs of IBM products.

Trademarks

IBM, Passport Advantage and Express are registered trademarks of IBM Corporation in the United States, other countries, or both.

Other company, product, and service names may be trademarks or service marks of others.

Terms of use

IBM products and services which are announced and available in your country can be ordered under the applicable standard agreements, terms, conditions, and prices in effect at the time. IBM reserves the right to modify or withdraw this announcement at any time without notice. This announcement is provided for your information only. Additional terms of use are located at

Terms of use

For the most current information regarding IBM products, consult your IBM representative or reseller, or go to the IBM worldwide contacts page

IBM United States