Scorecard: Approaches to Populating the Sponsor CTMS with CRO Data

Scorecard Overview There is a clear trend in the life sciences industry toward outsourcing clinical trial management to clinical research organizations (CROs). But, how do they get their trial management data back from those partners? There are several methods that pharma and medical device companies can use to collect clinical trial management system (CTMS) data from their CRO partners. This infographic presents the pros and cons of each approach. Note: Thescoresare based on cost, time to implement, and increases in efficiency once a method has been implemented.

Manual Data Entry by Sponsor

CRO provides sponsor with data extracts or reports; sponsor hand-keys data into their CTMS.

Pros

No additional technology investments No implementation time or costs

Cons

Time consuming Heavy human resource demands Not scalable Large margin for error No real-time data in sponsor CTMS

Ad Hoc Data Import by Sponsor

Data is entered into the CRO CTMS and then scrubbed, exported, and converted into a format that fits the sponsor CTMS requirements. Data is then imported through the user interface by the sponsor into their CTMS as often as needed for each study.* Data Entry in CRO CTMS Data Manually Imported into Sponsor CTMS

Data Scrubbing by CRO

Data Conversion

Export from CRO CTMS

Pros

Inexpensive Less room for error than manual data entry Faster than manual data entry Easy to modify export/import formats Minimal technical skills required

Cons

Data updates depend on clear communication between sponsor and CRO in an often hectic environment Mostly manual process: Need personnel and time to scrub and convert data before each import for each outsourced study Limited automated data validation prior to importing No real-time data in sponsor CTMS

*This process takes place for each data update for each outsourced study.

Manual Data Entry by CRO into Sponsor CTMS

Sponsor creates a user role in their CTMS for each type of contracted resource that will be performing data entry, creates user accounts and assigns roles, and provides each contractor at each CRO with a login ID and password for the sponsor CTMS. Each CRO contractor then enters data directly into the sponsor CTMS.

Create Roles

Create user roles in sponsor CTMS

Create Accounts

Create user accounts and assign appropriate roles

Provide Credentials

Provide user names and passwords Each CRO contractor enters data directly into sponsor CTMS

Direct Data Entry

Pros

No technical skills required; only the ability to use the sponsor CTMS As soon as the data is entered, it is available to the sponsor; no waiting for the export/import process No integration costs to incur No error logs to investigate and resolve

Cons

Requires time and resources to train personnel at each CRO Per-user license costs can be very expensive Increased burden on sponsor CTMS Administrators to manage user roles and accounts Increased burden on help desk personnel to support additional users Data standards can be difficult to enforce No opportunity for CRO to review data before it is made available to sponsor No error logs generated; errors must be found manually

Manual Data Entry by CRO into Tablet

Sponsor or CRO invests in tablets for contracted resources, which are loaded with the applications required by the sponsor. Contracted resources then enter data via the tablet directly into the sponsor CTMS.

Pros

CTM

Same pros as direct data entry, plus: Greater mobility for users Easier and faster data entry during monitoring visits Can be loaded with documentation and additional applications relevant to each resource

Cons

Same cons as direct data entry, plus: Tablet investment can be very expensive

Automated Data Integration

Sponsor defines the data points that they want automatically populated in their CTMS, as well as the business rules surrounding the data points. An interface based on those specifications is built into the sponsor CTMS, and then each CRO configures their CTMS to output the required data in the required format at the specified intervals. The interface then processes the data and automatically updates the sponsor CTMS, without human intervention.

CRO CTMS

Data entry Automated output of predefined data points into required format at specified intervals

Interface

Processes data in accordance with business rules

Sponsor CTMS

Auto-populated No human intervention

Pros

Scalable solution: no need to train CRO personnel on sponsor CTMS, so CRO resources can scale up, scale down, or change as needed without impacting data sharing process Can be used with any CRO capable of outputting the data in the required format Saves time otherwise spent on data entry, data conversions, etc. Automatically checks for errors; creates error logs when found Ensures higher data quality across all integrated CRO partners Provides clean data to sponsor as quickly as desired (interface schedule determined by sponsor)

Cons

Can be expensive to implement CRO and sponsor resources still required to address errors If not designed using a standard format, could lock sponsor into using specific CROs

So, What Should You Consider When Choosing a Data Population Method?

Data Turnaround

How quickly sponsor needs clean data available to them

Resources

Sponsor/CRO resources available for scrubbing and/or converting data Sponsor resources available for training CRO users of CTMS

Budget

Human resources, software licenses, system integrations

Work Volume

Number of CROs involved, number of resources involved at each CRO, number of studies being outsourced, complexity of studies

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