Leveraging SharePoint for Clinical Trial Management [PDF]

Bringing your projects to a higher level SM

Leveraging SharePoint for Clinical Trial Management 26 April 2011 Presented by Darcy Vieira, Cato Research Canada Jeremiah Rehm, BioClinica 1

 2010 by Cato Research Ltd. All rights reserved.

Agenda • • • • • • • • •

Cato Research’s Vendor Selection Process The Integration Challenge Traditional CTMS Model Microsoft SharePoint Separating the Study Data Logistical Data Specification Role-based Data Access Track and Measure Performance Suggested Vendor Questions

Bringing your projects to a higher level SM 2


Cato Research Qualified Vendor Database • • • • • • •

Clinical Trial Management System Patient Recruitment Phase I Units Central IRB Electronic Data Capture Central Laboratory Translational Services

• Call Center Services • Analytical Laboratory • Imaging • Nonclinical Facilities • Drug Packaging/Labeling/ Shipping/Storage • API/Drug Product Manufacturer



Vendor Selection for CTMS •

Standard operating procedure for vendor selection – Identification of potential vendors • Based on requirements from different stakeholders throughout the organization

– Development of vendor questionnaire • Points to consider: – Size of vendor and facility overview – Past project experience – Background and experience of personnel – Compliance with applicable regulations – Internal vendor procedures – Referrals Bringing your projects to a higher level SM 4


Vendor Selection for CTMS • Evaluate and compare vendor results – Demo presentations provided by vendor – Identify qualified personnel for further evaluation – Set-up of test environments for further evaluation

• Perform quality assurance audit of vendor



Global clinical trial solutions. Real-world results.

Leveraging SharePoint for Clinical Trial Management April 26, 2011

Today’s Clinical Trials

Many isolated eClinical systems

A multitude of complex study management environments 7


Complex Study Logistics

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Today’s Study Environment

Safety EDC

Clinical Site

IVRS

CRO

Clinical Site

CRO

CTMS

Clinical Site

Sponsor

EDC

EDC Clinical Site

CTMS

Clinical Site

Clinical Site 9


The Integration Challenge

Significant propagation of eClinical applications • Multiple product categories, all with overlapping functionality • Numerous vendors, each using a unique data specification

Targeted research: smaller players, more studies • Many more partnerships, acquisitions, and cross-organizational trials • Study costs are increasing, while trial budgets decrease

Dramatic escalation in selective outsourcing • Many specialized CROs offering diverse service models • Significant rise in international studies and sites • Each vendor’s report and/or data export uses a unique format, covers a different timeline, and provides disparate data types 10


Transferring Data Between Systems

Migration: the one-time population of data into a newly deployed system (e.g. investigator information from an Access database needs to be pre-populated into the CTMS). Periodic Import: the repetitive update of data based on a predefined schedule (e.g. mapping the multiple Excel files provided by various CROs to the sponsor’s CTMS). Integration: the automated one-way or bi-directional exchange of data between two systems (e.g. CRF page status transferred from an EDC into the CTMS’ financial component).

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Traditional CTMS Model

Locally Installed Applets

CTMS

Point-to-Point Connections

Office Systems Outside of CTMS

EDC

IVRS

Safety CRM

Other

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Next Generation CTMS

Multi-Study Management Environment

CTMS

Microsoft SharePoint

User-Targeted Office-Smart Environment

Connector

Office Systems Outside of CTMS

EDC

IVRS

Safety CRM

Other

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Microsoft SharePoint 2010

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Microsoft SharePoint 2010 1.

Sites: the basic capabilities required to engage employees, partners, and customers in an effective manner; both inside and outside the firewall.

2.

Communities: the ability to easily access expertise and interact with other people in new and creative ways across the enterprise through both formal and informal networks.

3.

Content: the facilities for the creation, review, publication, and disposal of content, including conforming to defined compliance rules, whether the content exists as traditional documents or as Web pages (includes document management, records management, and Web-content management).

4.

Search: the capability to enable users to quickly and easily locate relevant content across SharePoint lists, sites and external systems, and other data sources, such as file shares, Web sites, or line-of-business applications.

5.

Insights: the ability to not only rapidly deliver and share information that is critical to the success of the business, but also to turn raw data into actionable conclusions and to drive business results through sharing data-driven analysis.

6.

Composite Applications: the ability to quickly create customized solutions without involving corporate IT in each request. At the same time, the IT staff needs the capability to empower business users to create these applications while ensuring the environment’s stability and availability.


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Clinical Trial Management and SharePoint 1. Leverages existing investment in Microsoft products 2. Creates a more connected and collaborative environment 3. Consolidates cross-platform data for informed decisions 4. Streamlines clinical processes and workflow 5. Simplified workspace significantly improves user adoption 6. Lowers training costs and on-going support expenses 7. Delivers faster return on investment (ROI) 16


[Screenshot Slide]


[Screenshot Slide]


Separating the Study Data Study 1

Logistical Data

Study 2

Clinical Data

Operational Impact

1.00 0.90 0.80 0.70 0.60 0.50

Study N

0.40 0.30 0.20 0.10 0.00

Data Types


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Logistical Data Specification

Syntax

Semantics

• Data type definitions

• Context within the clinical trial environment

Define your specification or adopt one

Persistence • Consistency across studies with ability to extend per study Global clinical trial solutions. Real-world results.

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Role-based Data Access Microsoft Office

ODBC or other DB Connection

Microsoft Office System

Flat Files (CSV, etc.)

CRM

IVRS

Spreadsheets

CDMS

Web Services Clinical Applications and Services

Enterprise Applications and Services ERP eDM

Safety

EDC CTMS 21


Site Visit Calendar – CTMS View


Site Visit Calendar – SharePoint View


Site Visit Calendar – SharePoint Portal


Site Visit Calendar – Connect to Outlook


Site Visit Calendar – Outlook View


Populating SharePoint

Several technologies and options exist: • Business Data Catalog (BDC) • User Defined Function (UDF) • Web Services and SharePoint Content Types

Beware of functional limitations! • • • •

Connect to Outlook Export to Spreadsheet Open with Access SharePoint 2010 (embedded PerformancePoint analytics, graphical Visio workflow, native eSignature functionality, etc.)

More than just tracking data for regulatory compliance, use it to measure performance as well as improve operational efficiency via scorecard portals. Global clinical trial solutions. Real-world results.

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Track and Measure Performance


Track and Measure Performance


Common Study Functions

Clinical Trial Management System

Microsoft SharePoint

Provides controls for regulatory compliance

Presents relevant data to study stakeholders

Role-based, study-specific permissions Portals, dashboards, scorecards, etc. Audit trail, version history, record hierarchy, etc.

eSignature of document files (SharePoint 2010)

Configurable workflow and alerts

Custom workflow and alerts

Predefined report templates

Ad-hoc personalized reports

Tracks operational study data and record relationships

Calculates performance metrics based on operational data points

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SharePoint 2010 Edition Comparison


Vendor Questions • • • • • • • • • • • •

Do your products support exposing the data being tracked into SharePoint? Exactly what methods or processes do they use to do this? What are the limitations? Is a Test Drive available? Is it one-way only or bi-directional? Which record types specifically? What versions of SharePoint are supported (2003, 2007, 2010)? What flavors are required (WSS, MOSS, Enterprise MOSS)? Is the data specification extensible to include custom information? What security or permission controls are used? Role-based? Study specific? Full Active Directory support vs. Windows Integrated authentication? How is security, compliance, and data integrity ensured? Do you support Validation efforts? IQ/OQ/PQ? 21 CFR Part 11? What data standards do your products support (SDTM, MCC, etc.)?


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Agenda Revisited

• • • • • • • •

The Integration Challenge Traditional CTMS Model Microsoft SharePoint Separating the Study Data Logistical Data Specification Role-based Data Access Track and Measure Performance Vendor Questions

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Thank You! Questions? BioClinica, Inc. 800 Adams Ave. Audubon, PA 19403 (888) 392-7456 www.bioclinica.com

Upcoming Webinars Title: Leveraging SharePoint to Maximize CTMS Adoption and Flexibility Host: Applied Clinical Trials Date/Time: Wednesday, May 11, 2011 at 2:00pm ET Speakers: Les Jordan (Microsoft) and Bob Leonard (Harvard Clinical Research Institute) Free Registration: www.appliedclinicaltrialsonline.com/SharePoint Title: Source Documentation, Audit Trails and EDC, How Do They Fit Together? Host: Drug Information Association Date/Time: Wednesday, May 25, 2011 at 11:00am ET Speaker: Jonathan Andrus (BioClinica) Free Registration: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=26937&eventType=Webinar Global clinical trial solutions. Real-world results.

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