Source: http://www.google.com/patents/US7921125?dq=7,172,682
Timestamp: 2017-09-24 23:27:54
Document Index: 519378499

Matched Legal Cases: ['Application No. 61', 'art 14', 'art 3', 'arts 4', 'arts 20', 'art 15', 'art 17', 'arts 4']

Patent US7921125 - Virtual data room with access to clinical trial status reports based on real ... - Google Patents
A virtual data room distributes information associated with an investigational product, such as an investigational compound. The information includes documents associated with the investigational product; and reports based on live clinical study data of the investigational product. The live clinical...http://www.google.com/patents/US7921125?utm_source=gb-gplus-sharePatent US7921125 - Virtual data room with access to clinical trial status reports based on real-time clinical trial data
Publication number US7921125 B1
Application number US 12/898,369
Priority date Jul 20, 2010
Also published as US8266161, US20120023413
Publication number 12898369, 898369, US 7921125 B1, US 7921125B1, US-B1-7921125, US7921125 B1, US7921125B1
Inventors John W. Houriet, Jr., Ambalavanan Subbiah, Mario A. Paes
Original Assignee Numoda Technologies, Inc.
Patent Citations (15), Non-Patent Citations (31), Referenced by (6), Classifications (9), Legal Events (5)
Virtual data room with access to clinical trial status reports based on real-time clinical trial data
US 7921125 B1
A virtual data room distributes information associated with an investigational product, such as an investigational compound. The information includes documents associated with the investigational product; and reports based on live clinical study data of the investigational product. The live clinical study data includes cleaned and not cleaned data records. For a designated subset of data records, the reports use data associated with only cleaned data records, and for the remaining data records, the reports use data regardless of whether the data is associated with cleaned or not cleaned data records.
This application claims priority to U.S. Provisional Patent Application No. 61/365,904 filed Jul. 20, 2010.
A conventional “virtual data room” (VDR) (also, referred to as a “virtual deal room”) is an online repository of information that is used to store and distribute documents that need to be shared and disclosed among different entities. A VDR is often used to facilitate the due diligence process during financial transactions, such as a merger and acquisition transaction, or when an entity is deciding whether to make an investment in a company. The VDR replaces a physical data room that previously housed the repository of information, typically in paper form. In a VDR, the documents are stored in electronic format on a central server and accessed via the Internet. VDRs are assumed to be secure and confidential and a login ID and password is typically required to access the VDR. There are dozens of companies that host VDRs such as Merrill Corporation which provides the Merrill DataSite®.
A virtual data room distributes information associated with an investigational product, such as an investigational compound. The information includes documents associated with the investigational product and reports based on live clinical study data of the investigational product.
This patent application includes an Appendix having a file named appendix10001-32U1.txt, created on Sep. 24, 2010, and having a size of 62,769 bytes. The Appendix is incorporated by reference into the present patent application. One preferred embodiment of the present invention is implemented via the source code in the Appendix. The Appendix is subject to the “Copyright Notice and Authorization” stated above.
The present invention is described in the context of features provided in a web-based commercially available virtual data room product/service called TruPoints® marketed by Numoda Capital Innovations LLC, which is an investment and financing affiliate of Numoda® Corporation (Numoda), Philadelphia, Pa. Numoda Capital Innovations LLC hosts TruPoints. However, the scope of the present invention is not limited to this particular implementation of the invention. The present invention is described in the context of a plurality of distributed computers, all of which are linked together by an electronic network, such as a LAN or the Internet. The computers may be any type of computing device that allows a user to interact with a web site via a web browser. For example, the computers may be personal computers (PC) that run a Microsoft Windows® operating system. The computers may also be handheld, wireless devices.
“Real-time” as used herein can be completely real-time, or there could be periodic caching of data in the CDMS database so the real-time data would include the data from the last periodic caching.
Certain data records that are created have a status of being either “cleaned” or “not cleaned.” As is well-known in the clinical trial database management art, the “cleaned” data records have undergone some form or degree of data validation. A status flag is provided in the CDMS database for the data records which must be cleaned, and the status flag is changed or modified after the data record is cleaned. These status flags are known in the prior art but are conventionally used only to identify data records that need action taken to be cleaned, and not as a filter criterion for creating reports regarding the status of the clinical trial study, as described further below.
In addition to being “cleaned” or “not cleaned,” a data record or the entire clinical trial database may be “locked” or “unlocked.” There are various types of locks associated with clinical trial databases and data records (e.g., interim or soft locks, hard locks, full database locks), but they all have in common the fact that the data record either is allowed to be changed by certain or all users who have access to it (unlocked) or is not allowed to be changed by certain or all users who have access to it (locked). Typically, a data record is locked after it is cleaned, and thus it is common to refer to a data record as being “cleaned and locked.” However, these are usually two distinct steps.
Alternatively, data records can be designated as having been cleaned by being locked, thereby defining a one-step process with the lock functioning as a proxy for the data record being cleaned. For example, the lock may be in the form of a “soft lock,” in which data records associated with a piece or subset of data is locked from further editing by the study team but can still be unlocked up until the time that the overall database is formally locked and the study data is then typically submitted to biostatisticians for analysis as part of the unblinding process discussed above.
In a second embodiment of the present invention, when a report is generated for a CDMS user, it always pulls the most current data from the CDMS database, regardless of whether the data is associated with data records that are cleaned, but for a designated subset of data records, the report generated for the virtual data room only pulls data associated with “cleaned” data records from the CDMS database. The designated subset of data records that must be cleaned to be used in a report generated for the virtual data room is selected by the study sponsor or the administrator of the virtual data room.
In one example of the second embodiment, the “lock” status of the data records has no bearing on whether or not the data records are used in either the CDMS or virtual data room reports. Thus, a data record must only be cleaned to be used for a virtual data room report. In another example of the second embodiment, the “lock” status is used as another filtering criterion for generating virtual data room reports, and for the designated subset of data records, only data associated with locked data records are used for generating the virtual data room reports. Thus, in this example, a data record must be cleaned and locked to be used.
A third embodiment of the present invention is similar to the second embodiment in that the virtual data room only pulls data from the CDMS database based on the “cleaned” status of the data for the designated subset of data records, but with the extra constraint related to the status of the patient in the treatment regimen, whereas no such exclusion is made in the CDMS report. For example, the virtual data room would only pull data, or a subset of data, of patients who are at a designated stage of the treatment regimen, whereas a report generated for a CDMS user would not have these restrictions. This difference is highlighted in the virtual data room report shown in FIG. 13 which includes only patients who have completed the treatment regimen (i.e., “completed patients”), compared to FIG. 12 which shows a CDMS report that is not limited to completed patients. Likewise, the virtual data room report shown in FIG. 4 includes only “completed” patients (CRF status=C), whereas related CDMS reports are not necessarily limited in this manner. See, for example, the query preview filter in FIG. 10 which allows the CDMS user to select patients with a status other than “completed.” Again, a status flag is provided in the CDMS database for the patient status, and this flag must be set to “completed” for patient data to be shown in a virtual data room report. The status of being a “completed” patient is protocol-specific (i.e., it depends upon the clinical trial protocol), as is well-known in the art. Also, “completed” may refer to completed all treatment, completed one cohort, completed one doctors visit or the like. FIGS. 4, 10, 12 and 13 are discussed in more detail below.
The second embodiment described above allows the virtual data room to avoid exposing unvalidated/unchecked data to users who are not actually running the clinical trial. While it may be acceptable for a CDMS user to see reports that may contain unvalidated/unchecked data, a clinical trial sponsor would not likely want to allow potential investors and potential licensees to view reports having certain unvalidated/unchecked data, such as adverse event/safety data (FIG. 4) or unvalidated/unchecked patient symptom data (FIG. 13). In contrast to these types of data, certain less critical data such as patient enrollment data (e.g., the number of patients currently enrolled in the study) may be acceptable to show to virtual data room users, even if it is not cleaned. Regarding the third embodiment, a similar scenario may exist for patients who have not reached a certain designated status in the treatment regimen, such as “completed.”
FIG. 65 is a flowchart of one preferred embodiment for selecting data to be used to generate reports for the virtual data room in accordance with the second and third embodiments of the present invention described above. The data records needed to generate the desired virtual data room report are identified (step 110) and the first data record is examined (step 120). The patient status is optionally checked (step 130), and if the patient status is not in a designated status (e.g., “completed”), the data record is discarded (step 140) and the next data record is examined (steps 1110 and 120). If the optional patient status check is performed and the patient status is in a designated status, or if the optional step 130 is skipped, then the data record is checked to see if it belongs to a predefined subset of data records that must be “cleaned” to be used in a virtual data room report (step 150). If not, then the data record is accepted (step 1100) and the next data record is examined (steps 1110 and 120). If so, then the status of the data record is checked to determine if it is cleaned (step 160). If the data record is not cleaned, then the data record is discarded (step 170) and the next data record is examined (steps 1110 and 120). The status of the data record is then optionally checked to see if it is locked (step 180). If not (i.e., data record is unlocked), then the data record is discarded (step 190) and the next data record is examined (steps 1110 and 120). If so, or if the optional step 180 is skipped, then the data record is accepted and the next data record is examined (steps 1110 and 120). If there are no more data records to examine, then a report is generated using the accepted data records (steps 1110 and 1120). Otherwise, the next data record is examined (step 120).
a. The virtual data room provides the Symptom score report shown in FIG. 13, which is one example of patient blinded efficacy data. This report is displayed based on the screen layout definitions (report specifications) in FIG. 14 and Part 14 of the Appendix. The SQL statement to generate this report is shown in Part 3 of the Appendix. SQL Schemas for the tables and views used in this report are provided in FIG. 15 (dashed portions of which are prior art) and prior art FIGS. 16 and 17, and prior art Parts 4, 5, 6, 7, 10, and 11 of the Appendix. This report does not provide any hyperlinks that enable access to additional real-time clinical patient data. A subset of data records that must be cleaned before being used in this report may be identified and then any uncleaned data records related to this subset of data records would be filtered out before generating the virtual data room report. Specifically, at least steps 150 and 160 of FIG. 65 would be used when generating this report. The table labeled “TruPoints_SympScore_Patients” in FIG. 15 is used to implement this feature wherein the Active field is used to indicate a cleaned data record. Parts 20-22 of the Appendix further illustrate one preferred embodiment for identifying and selecting only cleaned CRF data (referred to in the source code as being “complete” data) for subsequent use in the table labeled “PatientPeakScore_Complete” in FIG. 15 which, in turn, is used to create the virtual data room report.
b. The CDMS provides the Symptom score report (also called the Site supplies summary report) as shown in FIG. 12. This report is displayed based on the screen layout definition in prior art FIG. 18 and prior art Part 15 of the Appendix. The SQL statement to generate this report is shown in prior art Part 17 of the Appendix. SQL Schemas for the tables and views used in this report are provided in prior art FIGS. 7, 16, 17 and 19, and prior art Parts 4, 5, 6, 7, 8, 9, 10, 11, 18, and 19 of the Appendix. This report provides hyperlinks to additional screens (prior art FIGS. 10, 11, 20 and 21), which display additional real-time patient clinical data. The screen shown in FIG. 20 is displayed by clicking on a hyperlink associated with the V2 Qualifier in FIG. 12. The screen shown in FIG. 21 is displayed by clicking on a hyperlink associated with the Randomization in FIG. 12. The screen shown in FIG. 10 is displayed by clicking on a hyperlink associated with the Patient ID in FIG. 12. The screen shown in FIG. 11 is displayed by clicking on a hyperlink associated with the visit and eCRF Name in FIG. 10. In contrast to the symptom score report shown in FIG. 13, at least steps 150 and 160 of FIG. 65 are not be used when generating this report, nor is a “TruPoints_SympScore_Patients” table used.
The Information Control Administration Module (ICAM) is used to specify which reports will be made available to users. Access to ICAM is controlled by a separate application called the Tracking System. In the Tracking System, usernames and passwords are assigned to Group Policies. The Group Policies are associated with Applications and access is configured accordingly. Users in the Tracking System which are assigned a Group Policy with access to the ICAM application can log into ICAM as ICAM Administrators (Admin). FIG. 22 shows the login screen for ICAM. The user enters their Tracking System username and password and then selects either one project or all projects from the project dropdown. For this example, the user has selected “XXXXXX-5132”. After the ICAM Admin logs in, they are defaulted to the “Users” page (FIG. 23). Here, an ICAM Admin is able to set up a TruPoints user's login information for the Information Presentation Module (IPM).
The main ICAM navigation is done first by Categories (FIG. 24 and FIG. 25), then Sub-Categories (FIG. 26, FIG. 27 and FIG. 28). The Sub-Categories are pages that the TruPoints user will see (FIGS. 29 and 30). There are two types of pages. One type of page is a list of documents associated with the clinical trial (FIG. 29). The other type of page is a report based on real-time clinical data (FIG. 30). These pages can be set to active or inactive status using the “Sub-Category”—“View/Edit” form (FIG. 31) and then selecting or clearing the “Active” check box. The database schema for the ICAM navigation is shown in FIG. 32.
To demonstrate the ICAM feature that specifies which pages can be made available to the user, the state of the “Current Studies”>“Subject Status” page (FIG. 33 and FIG. 34) will be changed from active to inactive. FIG. 33 and FIG. 34 show the “Current Studies”>“Subject Status” page in its active state. FIG. 33 shows the actual page and FIG. 34 shows the link to the page in the navigation pop-up menu. The ICAM Admin can make the page inactive by clearing the “Active” check box in FIG. 31 and clicking “Save”. While a page's status is “Inactive,” the link to it is removed from the Sub-Category links in the navigation pop-up menu. The navigation pop-up menu in FIG. 34 displays the “Subject Status” link while the “Active” check box is selected. While the Subject Status check box is not selected, the page's status is “Inactive” and the “Subject Status” link will not appear on the navigation pop-up menu (FIG. 35). The process is the same for all Sub-Categories or pages, whether they are lists of documents or reports with real-time data.
ICAM also includes a feature for specifying which documents on pages that are lists of documents will be made available to a user. For example, the “Current Studies”>“Protocol 09-001” page in FIG. 36 displays a link to the “09-001 protocol with amend 3 4 Feb. 2010 (PDF)” shown in FIG. 37. In FIGS. 36 and 37, the document's status is “Active”. To change the document's status to “Inactive,” the ICAM Admin can use the “Documents View”>“View/Edit” form (FIG. 38 and FIG. 39). The “Document View” in FIG. 38 is used by the ICAM Admin to find the documents in the IPM. After clicking the “View/Edit” link in the last column, the ICAM Admin will see the form in FIG. 39. With this form, the ICAM Admin can make the document inactive by clearing the “Active” check box and clicking “Save”. While the document is inactive, the link to it is removed from the list of document links on the “Current Studies”>“Protocol 09-001” page (FIG. 40). The database schema for ICAM document lists is shown in FIG. 32.
US20040152056 Jan 31, 2003 Aug 5, 2004 Lamb Cynthia Lee Method and apparatus for simulating a clinical trial
US20050055241 Sep 9, 2003 Mar 10, 2005 Horstmann Stephen P. Apparatus, system and method for clinical documentation and data management
US20050080721 Oct 12, 2004 Apr 14, 2005 Kearney Victor Paul Automated financial transaction due diligence systems and methods
US20060129326 Dec 10, 2004 Jun 15, 2006 Braconnier Paul H System for continuous outcome prediction during a clinical trial
US20100228699 May 21, 2010 Sep 9, 2010 Transenda International, Llc System and method for interacting with clinical trial operational data
WO2010071802A2 Dec 17, 2009 Jun 24, 2010 Sanjay Udani System for performing clinical trials
1 "Accelerate Your Clinical Trials," Intralinks for Life Sciences, Copyright © 2009 IntraLinks, Inc., printout from web address: http://www.intralinks.com/life-sciences-clinical-studies/, 2 pages.
2 "Anatomy of an ECM Solution," printout from web address: http://www.aiim.org/infonomics/anatomy-of-an-ecm-solution.aspx, Jul./Aug. 2009, 2 pages.
3 "Collaboration Platform unifies Bio-Pharm data, processes," Feb. 12, 2008, printout from web address: http://news.thomasnet.com/fullstory/539739, Tourtellotte Solutions Fusion DMC, 4 pages.
4 "Cost-Effective Document Management Solutions for Business-Critical Processes," IntraLinks® White Paper, Copyright © 2008 THINKstrategies, Inc., printout from web address: http://www.intralinks.com/articles/wp-saas-intralinks-p2.pdf, 9 pages.
5 "Effective Due Diligence," printout from web address: http://pharmalicensing.com/public/articles/view/995877551-3b5be2af61e34, printout date: Nov. 16, 2009, original posting date: unknown, 14 pages.
6 "Electronic Clinical Trial System Development with SharePoint," Copyright 2008-Shinetech Software Inc., http://www.shinetechchina.com/softwave/case-study/Web-parts.htm, original posting date: unknown, 3 pages.
7 "EMC Solutions for Life Sciences," printout from web address: http://canada.emc.com/collateral/industry-overview/h2131-life-sciences-brochure.pdf, Copyright © 2006 EMC Corporation, 12 pages.
8 "Managing the Business and Potential Opportunities," IntraLinks® product brochure, Copyright © 2009 IntraLinks, Inc., 2 pages.
9 "Pandesa ShareVault Enables Secure, Real-time Due Diligence for Biopharmaceutical Partnering," News release, Sep. 16, 2009, printout from web address: http://www.prweb.com/printer/2887304.htm, 2 pages.
10 "Protecting Sensitive Information in Life Sciences Organizations: Top Three Misconceptions that put Companies At Risk," Whitepaper from Brainloop (www.brainloop.com ), printout date: Nov. 2009, original posting date: unknown, 10 pages.
11 "Effective Due Diligence," printout from web address: http://pharmalicensing.com/public/articles/view/995877551—3b5be2af61e34, printout date: Nov. 16, 2009, original posting date: unknown, 14 pages.
12 "Electronic Clinical Trial System Development with SharePoint," Copyright 2008—Shinetech Software Inc., http://www.shinetechchina.com/softwave/case—study/Web—parts.htm, original posting date: unknown, 3 pages.
13 "Protecting Sensitive Information in Life Sciences Organizations: Top Three Misconceptions that put Companies At Risk," Whitepaper from Brainloop (www.brainloop.com <http://www.brainloop.com>), printout date: Nov. 2009, original posting date: unknown, 10 pages.
14 Ashish Kumar, "Digital Collaboration," Avanade Point of View, printout from web address: , printout date: Nov. 2009, original posting date: unknown, 15 pages.
15 Ashish Kumar, "Digital Collaboration," Avanade Point of View, printout from web address: <http://www.collaboratesimply.com/images/Avanade—DigitalCollaboration.pdf>, printout date: Nov. 2009, original posting date: unknown, 15 pages.
16 FirstPoint(TM) Enterprise Content Management product brochure. Copyright © 2008 Computer Sciences Corporation, 12 pages.
17 FirstPoint™ Enterprise Content Management product brochure. Copyright © 2008 Computer Sciences Corporation, 12 pages.
18 Francois Gossieaux, "Enabling Collaboration in the Pharmaceutical Industry," BioPharm, Jun. 2002, pp. 105-106, 2 pages.
19 Gale A. McCarty, "Clinical Trial Protocol Development and Multi-Center Site Management of a Medical Device Clinical Trial Using EMC Documentum eROO(TM) as a Virtual Workspace," Abstract of paper presented at "Clinical Trials and Clinical Research Expo 2005." Washington, DC, Oct. 24, 2005, 2 pages.
20 Gale A. McCarty, "Clinical Trial Protocol Development and Multi-Center Site Management of a Medical Device Clinical Trial Using EMC Documentum eROO™ as a Virtual Workspace," Abstract of paper presented at "Clinical Trials and Clinical Research Expo 2005." Washington, DC, Oct. 24, 2005, 2 pages.
21 Jens Backbom, "CSCW and the Enterprise: The Development of an eCollaboration Strategy at AstraZeneca Pharmaceuticals," Master of Science Thesis, Stockholm, Sweden 2008, printout from web address: http://www.collaboratesimply.com/images/Avanade-DigitalCollaboration.pdf, 56 pages.
22 Jens Backbom, "CSCW and the Enterprise: The Development of an eCollaboration Strategy at AstraZeneca Pharmaceuticals," Master of Science Thesis, Stockholm, Sweden 2008, printout from web address: http://www.collaboratesimply.com/images/Avanade—DigitalCollaboration.pdf, 56 pages.
23 John Postle, "Using SharePoint in a Regulated Environment." Life Science Leader, Jul. 2009, printout from web address: http://www.lifescienceleader.com/index.php?option=com-jambozine&layout=article&view=page&aid=3851, 3 pages.
24 John Postle, "Using SharePoint in a Regulated Environment." Life Science Leader, Jul. 2009, printout from web address: http://www.lifescienceleader.com/index.php?option=com—jambozine&layout=article&view=page&aid=3851, 3 pages.
25 Mark D. Uehling, "Clinical Trial Data Management: Tortured by Paper," Aug. 13, 2002, printout from web address: http://www.bio-itworld.com/archive/081302/tortured/html, 6 pages.
26 Michael Ball et al. "Using the Web to manage clinical trials," Innovations in Pharmaceutical Technology, 96-100, Phase Forward Inc., Dec. 2001, 4 pages.
27 Pandesa ShareVault for Pharmaceutical Partnering, printout from web address: http://www.sharevault.com/solutions/pharmalicensing.htm, printout date: Jul. 2, 2010, original posting date: unknown, 2 pages.
28 Sacha Pfeiffer, "The data room," The Boston Globe, Jan. 23, 2006, 4 pages.
29 VENUE, RR Donnelley & Sons Company, printout from web address: http://www.venue.rrd.com/wwwVenue/Solutions/Life-Sciences.asp, printout date: Nov. 16, 2009, original posting date: unknown, 2 pages.
30 Virtual Data Room, VENUE. RR Donnelley & Sons Company, printout from web address: http://www.rrdonnelley.com/wwwFinancial/CapitalMarkets/Solutions/venue-virtualdataroom-lifesciences.asp, printout date: Sep. 13, 2010, original posting date: unknown, 3 pages.
31 Virtual Data Room, VENUE. RR Donnelley & Sons Company, printout from web address: http://www.rrdonnelley.com/wwwFinancial/CapitalMarkets/Solutions/venue—virtualdataroom—lifesciences.asp, printout date: Sep. 13, 2010, original posting date: unknown, 3 pages.
US20110173021 * Dec 14, 2010 Jul 14, 2011 Numoda Technologies, Inc. Automated method of displaying and updating the status of clinical research sites in a clinical trial to identify readiness of sites to accept patients
US20120101838 * Oct 20, 2010 Apr 26, 2012 Helen Mary Lingard Systems and Processes for Managing and Supporting Regulatory Submissions in Clinical Trials
U.S. Classification 707/754, 707/783, 707/941
Cooperative Classification G06F19/363, Y10S707/941, G06F19/322
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HOURIET, JR., JOHN W.;SUBBIAH, AMBALAVANAN;PAES, MARIO A.;SIGNING DATES FROM 20100929 TO 20100930;REEL/FRAME:025125/0960