Compliance on the Journey to Commercial Success
For an early stage biopharma company bringing a new treatment to market, the complexities of compliance can be a speed bump on the road to commercial success. After successfully negotiating the issues involved with getting the product through clinical trials and regulatory approval, now there’s an entirely different body of regulations to contend with.
Whether building an internal sales and marketing team or engaging a contract sales organization, compliance is ultimately the company’s responsibility. But when salespeople engage healthcare organizations (HCOs), healthcare professionals (HCPs) and pharmacies, having a customer relationship management (CRM) system built with compliance in mind can turn many of the details of complying into standard operating procedures. If the CRM system is mobile enabled, it lets salespeople work from anywhere and also puts supporting tools directly in their hands at the point of interaction, making compliance a part of daily function rather than an additional burden.
What a system can do — and what it can’t
A mobile-enabled, pharmaceutical-specific CRM system supports best practices and procedures that are designed with compliance in mind. A configurable system allows the compliance officer to operationalize appropriate practices, supporting the company’s actions to uphold the laws of each country in which it operates.
Your CRM system can provide specific guidance as to the information exchange the salesperson should conduct with HCPs as well as approved detailing aids. It assists with managing distribution of those detailing aids, so they’re only pushed to individuals who are trained and certified. That is particularly advantageous for working with contracted sales organizations, where only some of the sales teams are certified on specific molecules.
Given the restrictions on in-person visits, digital channels are a vital part of the communications mix. A system that supports compliant emails distributed from the field, templatized with pre-validated content, keeps salespeople from having to re-invent the wheel each time. More important, it lowers the compliance exposure of one-off communication.
By no means can software cover every case, nor does it remove the need for compliance training. For example, if a physician asks a question about off-label use, the salesperson should politely end the conversation and hand the topic off to a medical science liaison who has greater freedom to handle medical inquiries.
On-the-spot signature capture
The ability to capture a signature with a mobile device on the spot capitalizes on opportunities that might otherwise be missed. For example, during a conversation, a salesperson can immediately look up in the system whether an individual physician has consented to receive communication about a particular product via a particular channel. If not, the salesperson hands the mobile device to the physician, who taps to indicate consent, signs it on-screen, enters any contact information necessary, such as an email address, and confirms everything.
A well-designed system prepopulates the screen with the information being confirmed or consented to, and presents it alongside the signature-capture window. This information cannot be altered by either the salesperson or the signer. Once the consent is signed and accepted, the system locks the confirmed or consented-to information to the signature so it cannot be changed, creating an ironclad audit trail.
A final word
Software, no matter how thoughtfully and carefully designed, can’t do everything in the realm of compliance. In conjunction with compliance training, it assists in tracking actions, documenting them, providing an audit trail and supporting the compliance officer’s efforts. A mobile-optimized, mobile- pharmaceutical-specific CRM system supports a systematic approach, avoids many of the pitfalls and helps pave the way to commercial success.
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