Rare Disease Commercialization
The Commercial Platform Behind a Rare Disease Launch
You have a therapy, a target approval date, and a plan with one line on it that reads stand up commercial. Behind that line sit eight workstreams. Where you start depends on what you already have in place
The Platform Cannot Wait for the Org Chart
Rare disease firms hire commercial operations late, and they do it on purpose. Headcount follows data readouts. Budget follows decision points. The first commercial ops lead often starts a few quarters before approval, sometimes after the hub RFP is already out the door. That sequencing is rational for a firm managing burn against a binary result. It also means platform decisions get made by people who will not be there to live with them
We run the build inside that gap. Vendor selection, the data foundation, medical affairs systems, and the integration architecture get scoped and executed while the org chart is still mostly empty, so your first hires walk into working systems instead of a folder of RFP responses. This is the same platform described on our rare disease CRM page, told as a sequence rather than a list of capabilities
Eight Workstreams, One Launch
This is the shape we see most often, and it is a starting point, not a script. Some firms come to us with the hub and pharmacies already picked. Some have systems cobbled together that we build around rather than rip out. Some staff medical later and start with the data work. Each workstream still depends on what the one before it settled, so we sequence around what you already have and skip what you have already solved. A few dependencies hold no matter where you start: the warehouse before targeting, vendor selections before partner integrations, and the target list before reps go live. This is the rare disease cut of our broader life sciences CRM work
Scoping and Vendor Selection
If your hub, specialty pharmacy, and 3PL are not picked yet, we help shape the RFPs and evaluate the responses with you. If they are, we start from their specs and skip ahead. Either way the deliverable is the same: a process flow covering the patient, the prescription, the product, and the data, a named system of record for each stage, an integration map, and a written risk assessment. Those decisions set the architecture for everything that follows. See how we approach hub integration
Medical Affairs CRM
When MSLs are your first field hires, and they usually are, medical affairs goes live before anything commercial. They need KOL tracking, scientific interaction logging, MIRF handling, and adverse event intake routing from their first week, not a spreadsheet that gets migrated later. We stand up medical affairs CRM with medical and commercial separation already enforced in the security model, and congress and advisory board activity logged alongside it. If your program staffs differently, this workstream slots wherever your hiring plan puts it
The Data Foundation
We stand up a commercial data warehouse in your own AWS account, provisioned as code so the environment is reproducible and auditable. Historical claims and prescription data from IQVIA or a comparable source gets loaded, validated, and profiled. Then the first analyses come out of it: where the treating providers are, where patients concentrate, and what the payer landscape looks like region by region. That output feeds targeting, territory design, and the market access plan
Partner Data Integration
Once the hub and the specialty pharmacies are contracted, we build the scheduled feeds: enrollment, benefits verification, prior authorization status, shipment, and dispense. Record activation waits on patient consent, so nothing lights up in the CRM before the paperwork supports it. File specifications get negotiated with each partner during onboarding. We run the validation that catches a format change before it reaches your users. The hub feed usually goes first
Patient Services
The first decision is who works where, and it is yours to make. Some programs put care coordinators in the hub's platform where the identified case lives, others keep case work in your CRM, and either way your field reimbursement managers work escalations on your side, routed by what is blocking therapy start, with the payer context they need before the visit. Your side receives de-identified case visibility from the hub, keyed to the tokenized patient identifier, so leadership can see where every patient sits between prescription and first dose without your systems ever holding a name
Commercial CRM and Field Force
Territories, tiered target lists, call planning, compliant rep email, and payer mix visible on the account. We deliver the commercial CRM MVP-first when timelines compress. The field launches with what it takes to work a territory, and enhancement releases follow on a set cadence after go-live. Managers get coaching visibility without another reporting tool bolted on. Reps trained on a lean system three weeks before launch adopt it better than reps handed the whole configuration at once
Targeting and Tiering
Targeting criteria get defined with your commercial team rather than handed to them. Diagnosis codes, procedure volume, referral patterns, and site of care become rules we apply against the claims data already sitting in the warehouse. The output is a tiered HCP target list mapped to balanced territories, delivered before reps hit the field instead of in month two. When the criteria change, we rerun them against the same data
Launch Analytics
Enrollment volume, time from prescription to first dose, prior authorization approval and denial rates, dispense trends, and field activity. We build these in Tableau or Power BI alongside Salesforce reporting, refreshed with every data cycle, so the numbers in Monday's meeting match the numbers in the warehouse. Every metric traces back to a source table, which means a figure nobody believes can be checked in a minute. Leadership gets the executive views they open. The field gets the operational views that change what they do that week
Spend Follows Decisions
Every workstream is scoped and authorized on its own trigger, so nothing gets committed before the decision it depends on is made. We start from what you have, and we work as a supporting party: you own the vendor awards, the operating model, and the compliance policy, and we bring the architecture, the build, and the recommendations. The platform runs on Salesforce Sales Cloud or Life Sciences Cloud, depending on your requirements, with an AWS-hosted data warehouse at the center
Authorized on Triggers
Each workstream has a trigger: a vendor award, a data readout, a headcount approval. We scope and quote against that trigger instead of one long agreement signed a year out. We sequence the build so the decision comes first and the spend follows it
Vendor-Neutral Foundations First
The warehouse, the data model, and the CRM foundation get built before partners are chosen, because none of them depend on which hub wins. Partner-specific integration work is committed only after the awards land, so you never pay to build against a vendor you did not pick
MVP First, Demonstrated Weekly
You see working software every week, in your own sandbox, with your own data. Scope adjustments come out of those sessions. When a date compresses, we cut to the version that lets the team work and schedule the rest as post-launch releases. Requirements get confirmed in working configuration, in short build-and-review cycles, instead of a long specification nobody rereads
Managed Services After Launch
The platform does not go quiet at go-live. Feeds get monitored, refresh cycles get validated, enhancements ship on a release cadence, and user support runs through a queue your team can see. Launch week starts the operating window, it does not close the project. As the treated population grows, patient-level targeting delivers fresh patient leads on every refresh
Compliance and Data Protection by Design
Built into the platform from the start rather than added at the end. Your compliance team sets the policy. The platform enforces it
Architectural Separation
Identified and de-identified data are kept apart at the architecture level. Anything extracted to the warehouse for analytics is de-identified before it is extracted
Encryption and Access Controls
Encryption in transit and at rest, role-based access, audit logging, and confidentiality obligations on everyone who touches the platform
Commercial and Medical Firewall
Medical affairs activity stays separated from commercial visibility inside the Salesforce environment, configured before the first commercial user logs in
Consent Enforcement
Consent captured at intake and enforced through record activation logic in every partner integration, so nothing about a patient moves until the paperwork supports it
Client-Owned Compliance
You own your compliance policies and regulatory documentation. We configure the platform to support them and never author policy on your behalf
Frequently Asked Questions
When should we start the platform build?
Before your vendor selections lock the architecture. Once the hub, specialty pharmacy, and 3PL contracts are signed, the integration points, file formats, and data ownership terms are largely set, and changing them afterward means renegotiation instead of design. Scoping ahead of those awards is the cheapest insurance a launch can buy. If your vendors are already signed, that is fine too: we start from their specifications, and nothing about the build requires having been there for the RFP.
The representative runway is about nine months from launch readiness, and it moves faster with strong involvement from your side: quick decisions, data and access on time, and the right people in the weekly sessions. Firms that reach us later still launch, but the sequence compresses and more scope moves into post-launch releases.
Do we need Veeva for this?
No. Salesforce covers the launch stack, on Sales Cloud or Life Sciences Cloud depending on your requirements: medical affairs, commercial CRM, patient services, and the integrations that move hub and specialty pharmacy data. We build on it.
Veeva is a capable platform and some firms have good reasons to pick it. For a first launch the tradeoff usually comes down to flexibility and contract length. Salesforce bends to a launch strategy that is still moving, and the commitment is shorter. We give you the honest read for your program rather than a default answer.
What does this cost?
Each workstream is scoped and quoted on its own. Nothing is committed before the decision it depends on is made, so you are not signing one number for work that hinges on a vendor award or a readout that has not happened yet.
The variables that move cost most are the count of partner integrations, whether the historical claims license is already in place, and how far the field force build gets compressed against the approval date. We walk through all three in scoping, before anything is priced.
What if our launch date moves?
It usually does. Workstreams are sequenced against decision points rather than calendar dates, so a shifted approval date moves the downstream schedule without invalidating work already delivered.
Buffers live where the dependencies allow. The data warehouse and the medical affairs build can run early and sit ready. Partner integrations cannot start until the awards are made, so those run on the tightest schedules and get the most attention when a date moves in either direction.
Do you run the platform after launch?
Yes. Managed services cover feed operations, data refresh cycles, enhancement releases, and user support. Most firms keep us on after go-live because the first two quarters generate more change requests than the build did.
The alternative is hiring an internal admin team before anyone knows what the platform needs day to day. We run it as part of the program for as long as the program runs, and the engagement grows as you add indications, markets, and data licenses.