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Products: CTMS Features

Having implemented Siebel Clinical since its inception, BioPharm Systems leveraged its expertise to create an "accelerator" - a pre-configured and enhanced version of the system that is designed to meet most organizations' requirements out-of-the-box. In this solution, ASCEND, we streamlined and enhanced the base modules that form Siebel Clinical, and added commonly requested features and functionality. Click on any link below to learn more.

 

 

Trial Setup/Administration
  • Perform trial setup/administration tasks in one centralized screen.
  • Use "template" functionality to create reusable document packages, subject visit schedules, study start-up task lists, investigator evaluations, etc.
  • Set up currency and exchange rate for studies and regions.
  • Associate multiple products to a single program.
Contact and Account Administration
  • Ensure data integrity of investigator database through controlled contact and account record administration.
  • Administer addresses in the Address Administration screen.
  • Administer addresses under Contacts or Accounts screens.
  • View only clinically-relevant tabs, fields, and dropdown values.
  • Capture Tax IDs for accounts and contacts.
  • Capture the type of IRB used by an account.
  • Auto-filter employees out of contact list.
Investigator Selection
  • Complete evaluations for investigators and sites.
  • Capture the name of the individual who completed an evaluation.
  • Perform basic queries to identify potential investigators.
  • Perform complex queries that span specialties, assessments, categorizations, and previous study experience to identify potential investigators.
Site Setup
  • Track IRB approval dates.
  • Associate multiple contacts to a site.
  • Define roles and specialties for each site contact involved in a clinical study.
  • Associate multiple accounts to a site.
  • Associate multiple addresses to a site.
  • Apply and complete document/task templates for study start-up activities.
Site Management
  • Track recruitment progress at the site level.
  • Track all investigational product and ancillary supply shipments to a site.
  • Track supplies/inventory quantities, lot numbers, and dates.
  • Track correspondence details for all site level inbound and outbound communications.
  • Track all subject visits rolling up to the site level separately from all other activities.
  • Generate mail merged follow-up letters for site contacts.
  • Apply and complete document/task templates for study conduct and close-out activities.
Subject Tracking
  • Capture basic subject identifiers.
  • Apply subject visit schedules from templates.
  • Record subject visit schedule activation dates for subjects.
  • Record subject informed consent dates.
  • Track subjects through the visit cycle and update subject statuses.
  • Record treatment arms for subjects.
  • Record treatment arms for subject visit activities.
  • Forecast subject visit dates based on subject visit schedule templates.
  • Capture "Unscheduled" visit records.
  • Track CRF information for unscheduled subject visits.
Investigator Payments
  • Track site contracts.
  • Create site budgets that accommodate withholding percentages or amounts.
  • Track investigator payments.
  • Track turnaround times for payments.
  • Automatically carry over budgeted costs for subject visits to payment request line items.
  • Process and approve payment requests using a workflow.
  • Designate an individual (contact) as a payee.
  • Designate an organization or company (account) as a payee.
  • Reconcile and report on payments.
Site Visits - Trip Reports
  • Track site visits.
  • Track protocol deviation details for a site or subject.
  • Import protocol deviation records into trip report.
  • Track adverse event details for a subject.
  • Import serious adverse event records into trip report.
  • Review and approve trip reports using a workflow.
  • Create trip reports and review trip reports in separate views.
  • Track turnaround times for trip report submissions and approvals.
  • Track site follow-up items outside of a trip report; import the relevant records into a trip report.
  • Track CRF-related dates outside of a trip report; import the relevant records into a trip report.
  • Capture an automatic subject enrollment snapshot in a trip report.
  • Pull visit checklists containing yes/no and narrative-answer questions into a trip report by applying a pre-defined template.
  • Capture an audit trail of trip report status changes within a trip report.
Study Management
  • View data roll-ups, graphics, and reports for all regions and sites within a study.
  • View rolls-ups of Site Addresses, Site Contacts, Site Adverse Events, Site Follow up Issues, Site Protocol Deviations, Site Supplies, Subject Visits, and Site Visits.
  • Associate and track accounts that are related to a study (e.g., Labs, Vendors, IRBs, CROs, etc.)
  • Associate and track contacts that are related to a study (e.g., contractors, vendor contacts, KOLs, etc.)
  • View recruitment progress across a study.
  • Track correspondence details for all study-level inbound and outbound communications.Track protocol-specific expenses.
Protocol Amendments
  • Create new subject visit schedule versions without losing any history.
  • Track subject visit schedule activation dates for protocol amendments.
  • Apply amended subject visit schedules to sites.
  • Apply amended subject visit schedules that do not require new informed consent without losing any subject visit or investigator payment history.
Document and Task Tracking
  • Apply and complete document and task templates for sites, protocols, regions, accounts and contacts.
  • Track expiration, sent, received, completion, approval, sign off, and IRB submission dates for documents.
  • Track whether a document activity has regulatory impact.
  • Sort documents by those with regulatory impact.
  • Assign and track sequence numbers for tasks.
  • Link a document to an external location via a URL.
  • See documents and tasks in separate views.
General
  • Ability to copy records across the application.
  • Audit trail recording the time, date, and user ID associated with each change.
  • International date format throughout the application.
  • Consistent address format throughout the application.
  • Ability to set alerts on the Home page.
  • Easy navigation to areas of clinical interest from the Home page.
  • Navigation from the Home page to pending trip reports assigned to the logged in user.
  • Spell check functionality for large text fields.
Reporting
  • Generate canned reports from the application.
  • Display custom logo in reports.
  • Generate robust trip report that displays site and visit details, real-time enrollment statistics, visit attendees, checklist item responses, narrative question responses, trip report approval history, areas for signatures, monitored follow-up items, CRFs, protocol deviations, and serious adverse events.
Advanced Investigational Product Tracking*
  • Set up inventory locations.
  • Create transaction records from location to location or from location to site.
  • Record quantity shipped, quantity destroyed, quantity on hold, etc.
  • Generate a report that shows drug lot, inventory accountability, and actuals at locations.
Electronic Signature on Trip Reports*
  • When changing a trip report status, confirm that the action is intentional and correct.
  • When approving a trip report, re-enter security credentials (User ID and Password).
  • See proof of the electronic signature on the trip report.
Protocol Progress Report*
  • Enter key metrics and performance indicators for each protocol.
  • Generate a Protocol Progress Report for upper management as often as necessary.
Safety Letter Tracking*
  • Create safety letter records for products, and attach copies.
  • Indicate which people at various sites need to receive safety letters and when.
  • Generate lists of recipients for safety letters that automatically remove duplicates.
  • Auto-create safety letter records for sites that meet the safety letter criteria - even sites that start late.
  • See if the appropriate product safety letters have been sent to the correct sites.
  • Prevent safety letter records from being regenerated or deleted after they have been sent.
System Documentation and Training
  • Complete User Guide included.
  • Validation-ready.
  • Validation suite available.
  • Train-the-Trainer training course and materials available.
  • Administration training course and materials available.
  • Supplemental training package available.
  • Data Standards Template available.
  • Standard Operating Procedures (SOP) package available.

*These modules are based on the same concept as ASCEND; each module comes pre-configured to meet most companies' requirements out-of-the-box and they can be implemented for a fraction of the time and cost. While these modules are designed to be used with ASCEND, we can also work with organizations to incorporate and implement them for their custom Siebel Clinical systems.

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