A global pharmaceutical laboratory was aiming to provide 2,000+ Sales Reps and MSLs with the most adapted business rules about “free text” usage in Veeva CRM.
Context
With the increasing amount of policies and rules, implementing collaborative tools is quite challenging in the Life Science sector.
In particular the enablement of “free text” fields in commercial solutions like CRM may increase risks of non-compliance.
- Off-Label Promotion and Discussions
- Product Safety Information
- “Fair Balance” Product Promotion
- Anti-Kickback Violations
- Competitor Mentions
- Personally Identifiable Information
- Privacy legislation – right of access to personal and professional data
- Personal Health Information
However it is obvious that tracking interactions with HCP and HCO in a CRM systems is crucial for medical and sales effectiveness.
As HCP reactions and HCO priorities cannot be fully predicted and automated, free texts helps to catch educational needs, continuously update medical practices knowledge, adapt services to client’s expectations, capture medical insights and reinforce the good use of pharmaceutical products.
Besides, free texts help sales forces to remember their last calls and properly prepare the next ones, so as to follow their commitments and engage customers. Call notes are recognized by Healthcare specialists as a key driver for the overall call success.
MSLs and Sales Rep work more efficiently when relevant information is shared. Most CRM solutions allow to run reports and configure user roles to limit data access to those authorized personnel. Compliance is indeed improved since data are stored into a single, auditable and accessible system (on the contrary to emails, notebooks, handwritten notes, secondary grey systems…).
Mission
First step consolidated different documentations and best practices into one simple but comprehensive document dealing with most common situations involving “free text” usage.
Internal and external resources were used, such as Veeva CRM job aids and educational materials, responsible communication materials, company rules…
Numerous interviews were then performed to collect feedback and intelligence from Medical, Commercial, Marketing, Compliance, Legal, Privacy and IS stakeholders across 20 countries.
Final step was to deliver shared and approved guidelines to enable free texts in Veeva CRM and monitor its usage in a compliant way.
Results
How to request a new free text field?
| As Business/Veeva process owner | • The reason to request a free text must be necessary, legitimate and relevant • Free texts should only be used to capture factual records and respect privacy obligations • Product safety information (adverse events and special situations) should not be reported in free text field as a default rule • Expected content, data entry, sharing rules, process control must be clearly defined |
| As IS/Veeva solution lead | • Work request must follow the approval and release management process • Free texts must be avoided if other data capture options exist for the same result • Instructions to remind being compliant can be implemented within Veeva application • Outbound interface must be assessed, approved and documented for a full traceability of free text data |
| As Business/Veeva process owner | • Pharmacovigilance must be informed for new text fields in the work request process • When the request is approved, educational material must be updated accordingly • Impacted user training must be rescheduled • Monitoring reports must be updated |
How to use free texts in Veeva CRM?
| As Veeva user | • A free text field must be used for its expected purpose solely • Veeva users must follow the company’s guidelines and trainings on free text usage and responsible communication • Free texts must be limited to factual and business relevant information • Veeva users must meet privacy obligations. Unnecessary, excessive, irrelevant personal information and personal opinions be captured • In case of doubt, Veeva users may not use free texts and ask for support |
| As Business/Veeva process owner | • Initial and repeated trainings on free text usage must be scheduled, including examples of good and bad practices • Training materials should mention local points of contact so that to Veeva users can ask for support of free text usage |
How to monitor free texts?
| As Business/Veeva process owner | • Spot checks must be recurrently performed by running Veeva reports on free texts samples • Frequency and method is correlated to the captured information typology, volume and level of risks • The one who runs the reports cannot be the one who captured the information in Veeva • He must follow the defined and appropriate monitoring procedure for each free text |
| As Back office/Controlling team | • Controller may be a process owner and/or affiliate equivalent back office function and/or a compliance officer and/or pharmacovigilance team or at list should be accurately trained by the pharmacovigilance team • Controls must be based on applicable guidelines and internal procedures • Controls must be documented : source documents, significant exchanges, control’s results, corrective actions • Method can foresee that some obvious anomaly will be handled at the business process owner’s level, and others may require to be escalated • Controller must inform the necessary group at affiliate level of the results as defined in the controlling method |
| As Management team | • Results are reviewed at adequate intervals in order to assess trends and recurrent issues • Trends or necessary specific cases should be communicated by the management teams according to the affiliate’s organization (example : department head, compliance, QA…) • Minutes of meetings are documented • Actions plans are communicated to business owners for corrections following internal procedures • We should ensure that Internal Audit is aware and could include Veeva CRM in an annual audit plan if appropriate |
How to automate the controlling?
| As Legal, Privacy, E&C team | • Legal/Privacy office may inform IS/Veeva solution leads and Business/Veeva process owner of any/major legislation updates in regards to free texts • Local E&C or affiliate equivalent must inform regional teams of local legislation updates as well |
| As Business/Veeva process owner | • Training materials and monitoring procedures must be updated if it is necessary and/or if legislation changes |
| As IS/Veeva solutions lead | • The list of available free text fields in Veeva must be continuously updated, reflected in Veeva reports to extract samples • List of available free text fields must be available for regional compliance on demand • IS must constantly assess existing tools with respect to the automation and securing of the free texts’ monitoring, including “bad word” detection, Pharma standards updates, spell-checker… |
| As new project team | • Business, E&C and IS teams should work together on any relevant business cases • If necessary, a proof of concept can be launched to elect the right solution • New processes and improvements should be approved by the existing CoE managed by IS |