Top 10 Reasons Why
You Need a CTMS
Param Singh
Welcome & Introductions
Param Singh Vice President of Clinical Trial Management Solutions
• 10+ years of experience implementing Siebel Clinical
• Managed over a dozen Siebel Clinical implementations
Welcome & Introductions
CTMS Practice Services
Implementation Manage implementations of Siebel Clinical, whether custom builds or our out-of-the-box accelerator, ASCEND.
Integration Build interfaces between Siebel Clinical and other clinical systems.
Training Develop and/or deliver standard and custom training classes and materials
Process Guidance Provide insight, advice, and solutions to specific CTMS issues based on industry best practices.
Today’s Agenda
Time (CDT) Topic
9:00-9:05 Welcome and Introductions
9:05-9:30 Count Down of Top 10 Reasons Why You Need a CTMS
9:30-9:45 Live Demonstration of 2 Features, Voted on by You
9:45-10:00 Q&A
Reason #10
Simpler Maintenance
Maintain one commercial system, usually with support from the vendor, rather than multiple spreadsheets and/or home-grown databases.
Reason #10: Why?
• Minimal duplicate data entry and error resolution
• No confusion about the stored location or most current version
• No need to maintain expertise in house; rely on vendor
– Vendor supplies updates, patches, and bug fixes
• Hosting makes it even simpler; no need to maintain IT infrastructure
Reason #9
Centralized Investigator Database
Store past, present, and future
investigator information in a central
location that can be
queried during
site selection.
Reason #9: Why?
• One master record with multiple read-only “associations”
– People, organizations, and addresses are stored separately and then associated to one another as appropriate
• Centralized maintenance = cleaner data
• Can capture additional metadata from standardized dropdown lists
• Easier to query
Reason #8
Transparent Financial Tracking
Monitor planned costs vs. actual spend
vs. outstanding balances for
investigators, sites, sponsors, and
vendors.
Reason #8: Why?
• Investigator payments, IRB fees, vendor expenses, etc. in one place provides a comprehensive picture
• Enforces business rules and SOX compliance through payment statuses that can only be updated by authorized users
• Helps to identify potential cost savings and to plan better for future trials
Reason #7
Streamlined Document Tracking
Create standardized lists of documents
to be collected over the course of
various types of trials, and track
standardized dates and
other information
against those lists.
Reason #7: Why?
• Enforces standardization and consistency in the information gathered and the method for gathering it
• Allows users to update multiple document records and/or fields simultaneously
• Enables quick identification of documents that are still outstanding, expired, about to expire, etc.
Reason #6
Increased Recruitment Visibility
Track subject enrollment across studies and clinical programs against planned targets.
Reason #6: Why?
• Identify high- vs. low-performing investigators
• Learn which sites are experiencing the greatest number of screen failures and early terminations – and why
• Capture metrics on planned vs. actual recruitment
• Accurately plan monitoring resources
Reason #5
Ability to Integrate
Streamline processes even further
through automated interfaces
with other clinical
systems.
Reason #5: Why?
• One “source” system for each kind of clinical data
• Fewer data entry/maintenance resources needed
• Less data investigation and correction needed
• No need to log into multiple systems to find answers
• Processes are completed consistently and quickly
Reason #4
Greater Compliance
Adhere to regulatory requirements and
guidelines through user access
controls, enforced processes, and
behind-the-scenes
tracking, such as
audit trails.
Reason #4: Why?
• Much easier to validate and keep validated/controlled than spreadsheets
• Much easier to control access: system as a whole and specific records
• Fewer deviations
• Greater data integrity
• Smoother audits
Reason #3
Robust Reporting
Answer questions quickly and easily
with ad hoc and canned reports
that query one
centralized database.
Reason #3: Why?
• Stores historical and current data
• Stores ALL clinical trial data, from subject recruitment to vendor payments to investigator information
• Offers high level and detailed reporting capabilities
• Provides access to real-time data, especially with integrations; no more out-dated reports
Reason #2
Informed Decision-Making
Identify trends and inconsistencies
across investigators,
trials, and business
units.
Reason #2: Why?
• Real-time, comprehensive data enables nimble, smart decision-making
• Identify strengths and weaknesses in PIs, vendors, and even your own organization
• Identify areas of risk and put processes in place to mitigate
• Make changes to current trials and plan better for future trials
Reason #1
Scalable Growth
Increase the number and size of the
trials you manage with fewer additional
resources.
Reason #1: Why?
• No organization can afford to spend exponentially to grow exponentially
• Scalable software solutions are the answer
• CTMS consolidates and streamlines subject tracking, investigator payments, document tracking, financial tracking, site monitoring, and more, allowing you to manage more and larger trials with less
Top 10 Reasons Why You Need a CTMS
10. Simpler Maintenance
9. Centralized Investigator Database
8. Transparent Financial Tracking
7. Streamlined Document Tracking
6. Increased Recruitment Visibility
5. Ability to Integrate
4. Greater Compliance
3. Robust Reporting
2. Informed Decision-Making
1. Scalable Growth
Cast Your Vote!
Possible Choices: • Clinical Administration - Study Setup
• Investigator Payments
• Protocol Expense Tracking
• Document Tracking and Document Packages
• Investigator Database
• Site Setup
• Site Management
• Subject Tracking and Recruitment Visibility
• SOP Compliance and Templates
• System Reporting
Siebel Clinical ASCEND
Q&A
Closing
Thank you for attending!
This webinar will be posted on www.biopharm.com
within 24 hours
+1 877-654-0033
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