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

psingh@biopharm.com

+1 877-654-0033

+44 (0) 1865 910200