When is the right time to bring medical information systems in-house? For many small and emerging biotech companies, the answer depends on timing, resources, and readiness. That was the case for scPharmaceuticals. About one year before its drug-device combination product received FDA approval, the company started working with a CRO to manage medical information requests. <\/p>\n
\u201cAt the time, we were just getting started and outsourcing made sense,\u201d says Katie Luepke, executive director, scientific communications, drug information, and publications at scPharmaceuticals. \u201cThe partner had the infrastructure and we had the content. It was a smart setup.\u201d This model is common among early-stage companies, especially before commercial launch. But as businesses grow, many reach a turning point \u2014 when increasing complexity and inquiry volume prompt the question: when is the right time to make a shift?<\/p>\n
Luepke and I explored this theme in the Medical Affairs Professional Society (MAPS) podcast, \u201cThe Tipping Point: When to Bring Medical Information Systems In-House.\u201d She shared why and how scPharmaceuticals shifted toward owning its own system, and the results she and the team have seen since. Her experience offers a practical roadmap for other biotech teams approaching similar decisions.<\/p>\n
The decision to bring medical information systems in-house is rarely driven by a singular challenge. More often, it\u2019s the accumulation of small, missed opportunities for quicker response, or greater data visibility alongside the budget friction that comes with growth. Owning your medical information system anchors process, data, and content to your operations, enabling control, even as dynamics change around you. For many companies, CROs remain valuable partners to operate contact centers and provide additional capacity, but system ownership allows for flexibility in deciding what to outsource.<\/p>\n
For scPharmaceuticals, fully outsourcing medical information was a practical decision in the lead-up to its product launch and came with a number of benefits. As the business grew, a few inefficiencies emerged that prompted Luepke and her team to rethink their approach. \u201cWe realized we could potentially manage medical information ourselves \u2014 streamline the process, improve turnaround times, and hire someone internally with deep product knowledge and expertise,\u201d she says. <\/p>\n
The CRO handled most logistics and first-line responses but complex inquiries were often escalated \u2014 many landing with Luepke. \u201cWe hit a roadblock in the speed in which responses were transmitted. In some cases, it took as long as three days to send a response,\u201d she says. <\/p>\n
Cost control was another key driver. Their contract was fixed to a monthly volume of medical information questions and exceeding those thresholds meant added cost. As scPharmaceuticals launched a new product, inquiries increased and invoices began to add up quickly. \u201cWith any small pharma company, you have to be very budget-conscious during a launch,\u201d Luepke says. \u201cCost savings are what really caught our attention. We justified the change financially and our colleagues were excited about a more streamlined approach.\u201d<\/p>\n