Update to Entering and Reviewing Data for 3500A Reports (End User)

Added new fields for reporting adverse events on Form 3500A so that it complies with the new FDA mandate.

Electronic Signature Capture for dispersed samples.

See Recording Calls in Pharma.

Users can capture signatures for samples disbursement within Siebel Pharma running on a mobile client.

Closed-loop marketing

See Recording Calls in Pharma.

In the contact call record, sales representatives can note the professional's response to specific marketing campaigns. (The campaign manager can later review all responses to estimate the effectiveness of the campaigns.)

Managed care business plans.

See Managing Managed Care Accounts.

Managed-care account managers create business plans outlining how they can work with MCOs to promote the use of their company's products by members of the health plan.

Routing time off territory records

See Tracking Time Off Territory.

Routing rules can no longer be edited in the Siebel Remote Administration screen. If you need to edit routing rules, contact Siebel Expert Services.

Protocol Versions

Setting Up and Carrying Out a Clinical Trial.

Protocol versions are now administered and tracked through a dedicated view. When a new protocol version is applied, non-applicable subject visits are automatically deleted. Non-applicable subject visits are also deleted if the subject terminates the trial early.

Site Calendar

Setting Up and Carrying Out a Clinical Trial.

The new Site Calendar displays all subject visits at a site, and site visits made by CRAs.

Rolling-up Subject Enrollment Information

Setting Up and Carrying Out a Clinical Trial.

Subject information is automatically rolled-up from Sites to Regions to Protocols and directly from Sites to Protocols. Information for subjects and sites for which the clinical organization is not responsible (for example, trials outsourced to CROs) may also be rolled-up.

Associating Multiple Contracts with a Site

Managing Sites and Clinical Contacts.

Multiple contracts may be associated with a site through a new Contracts view. The total contract value for a site is equal to the sum of the individual contract values.

Creating Site Visits

Managing Sites and Clinical Contacts.

Site Visits are created and managed through a new Site Visits view.

Assessing Accounts

Managing Sites and Clinical Contacts.

Accounts, such as hospitals, may be assessed to determine fitness to carry out a clinical trial.

Clinical Payments

Setting Up and Making Subject Activity Payments.

Withholding Amounts and Percentages may be applied to payment activities to make sure all activities are completed before payment is made. Financial administrator can generate payments when payment activities are completed. Earned to Date and Paid to Date fields automatically roll-up from sites to regions and protocols, and from region to protocols.

Trip Reports

Administering and Using Clinical Trip Reports.

Dynamic trip reporting based on visit types complete with different Actuate Trip Reports for different visit types. Trip reports can be approved or reject by manager before they are distributed.

Medical Advanced Contracts.

See Siebel Advanced Contracts.

Made minor changes to the text to improve document accuracy.

Medical Advanced Contracts.

See Siebel Advanced Contracts.

This new feature manages complex contracts. The feature keeps track of benefits, conditions, terms, and compliance history associated with the contracts.

Adverse Events and Complaints Management.

See:

Capturing Adverse Events and Complaints.

Investigating Adverse Events and Complaints.

Recording Product Analysis for AECM.

Managing CAPAs.

Regulatory Reporting.

Communicating with Customers for AECM.

Closing Adverse Events and Complaints.

This new feature manages adverse events and product complaints for the regulated medical device and pharmaceutical industries. It manages information throughout the life cycle of a complaint: from capturing and investigating, through to reporting, resolving, and closing out.