Pharma Training That Passes Audits

Train medical reps, MSLs, and compliance teams with AI simulations that generate auditable evidence. RDC 658, FDA 21 CFR Part 211.25, and ICH Q9 ready.

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100%

Sessions documented

50+

Engagement badges

Languages supported

0-100

score per criterion

Real challenges

What blocks training today

What we hear from training leaders in real conversations. No fluff.

Training costs are explosive

Flying reps to headquarters for face-to-face role-plays costs thousands per person. You need scale without the logistics.

Audit trail is manual

Spreadsheets, sign-in sheets, and paper forms don't survive a serious ANVISA or FDA audit. You need digital, verifiable evidence.

Reps struggle with skeptical HCPs

New reps freeze when a cardiologist challenges their data. They need safe practice before real visits.

Visual aids aren't trained properly

Reps present visual aids without mastering the clinical data behind each slide. Compliance violations follow.

No way to measure training quality

You know reps attended training. But did they actually learn? Without objective scoring, you're guessing.

Regulatory updates break scripts

When ANVISA updates RDC 658, every rep needs retraining fast. Traditional methods can't keep up.

How Roleplays solves it

For every pain, a concrete answer

Segment-specific features mapped to each pain point above.

HCP persona simulation

AI-powered doctors, pharmacists, and nurses with configurable specialties, skepticism levels, and objection patterns.

Label compliance scoring

Automatic evaluation of label adherence, detect when reps go off-label or miss critical safety information.

Visual aid training mode

Simulate full medical visits with visual aid presentations. AI evaluates slide-by-slide clinical accuracy.

Audit-ready reports

Export complete training records per rep: sessions, scores, criteria met, timestamps. ANVISA-ready format.

Regulation-linked templates

Pre-built scenarios linked to specific regulatory requirements (RDC 658, FDA 21 CFR). Stay compliant by design.

Multi-product launch readiness

Ramp up entire sales forces on new products in days, not weeks. Parallel training across therapeutic areas.

See a real session

One conversation.
One rubric.

An example roleplay in this context. Each turn is scored against your tenant competency framework.

Scenario

Medical visit to present a new GLP-1 agonist for Type 2 Diabetes. The HCP is skeptical about cardiovascular safety data.

Rubric criteria

Label complianceClinical data accuracyObjection handlingEthical communicationClosing technique

Dr. Helena Nakamura

Endocrinologist, University Hospital

in session

Good morning. I have 10 minutes before my next patient. You wanted to discuss your new GLP-1 agonist?

Yes, Dr. Nakamura. Our phase III SUSTAIN trial showed HbA1c reduction of 1.8% compared to placebo over 56 weeks.

HbA1c reduction is expected with GLP-1s. What concerns me is the cardiovascular safety profile. The LEADER trial for liraglutide took years. What's your CV data?

Great question. Our CVOT showed non-inferiority for MACE, with a hazard ratio of 0.74, which actually suggests potential CV benefit...

Non-inferiority is one thing, but 0.74 HR, was that pre-specified or a post-hoc analysis? I need to see the confidence intervals.

Type your reply...

Compliance & framework

Evidence that survives audit

Every session generates exportable evidence with timestamps and per-criterion scores. Audit ready.

RDC 658 / ANVISA

Good Manufacturing Practices training with documented evidence for ANVISA audits.

FDA 21 CFR Part 211.25

Personnel training requirements with verifiable records of each session.

ICH Q9 / Q10

Quality risk management training and pharmaceutical quality system compliance.

LGPD

Patient and HCP data handling training with privacy-by-design architecture.

FAQ

Frequently asked questions

Questions that come up in almost every first conversation.

How does Roleplays help with ANVISA audits?

Every training session is recorded with timestamp, participant ID, scenario details, evaluation scores, and AI feedback. Reports can be exported in audit-ready format, showing exactly what each rep was trained on, when, and how they performed.

Can we create scenarios for specific therapeutic areas?

Yes. You can create custom HCP personas by specialty (cardiologist, endocrinologist, dermatologist, etc.), set difficulty levels, and define evaluation criteria specific to each drug or therapeutic area.

How does the label compliance scoring work?

A specialized AI evaluation model checks every rep statement against the approved label information. If a rep makes an off-label claim, misquotes efficacy data, or omits safety information, it's flagged automatically with a specific criterion score reduction.

Can we train reps in multiple languages?

Yes. Roleplays supports 23 languages. You can train the same scenario in Portuguese, English, Spanish, and more, critical for multinational pharmaceutical companies.

What about data security for patient/HCP information?

A Roleplays vállalatonkénti adatbázis-elszigetelést használ. Az Ön adatai teljesen el vannak választva a többi ügyfél adataitól. We're LGPD compliant and working toward SOC 2 certification.

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