Turn post-approval safety into real-world evidence.
Cliorbit supports pharmaceutical, biotech, nutraceutical and medical-device companies with structured PMS, PSUR support, Phase IV studies, adverse event workflows, patient registries, medical-device vigilance and India-focused post-market documentation.
Built for sponsors, Marketing Authorization Holders, CROs, importers, manufacturers and healthcare product companies that need regulatory-ready safety documentation and real-world post-launch insights from India.
Approval is not the end of product responsibility.
It is the beginning of real-world safety monitoring.
After launch, a product may be used by elderly patients, children, patients with comorbidities, patients taking multiple medicines, rural and urban populations, private hospitals, specialty clinics and different prescribing environments.
Rare adverse events, long-term outcomes, misuse patterns, drug interactions, device-related complaints or tolerability issues may only become visible after wider market exposure.
- ✓Detect safety patterns before they become larger regulatory or patient-safety concerns.
- ✓Maintain PSUR, adverse event, registry and post-market documentation in a structured way.
- ✓Generate India-specific real-world evidence for lifecycle, label and risk-management decisions.
What is Post-Marketing Surveillance?
Post-Marketing Surveillance, or PMS, is the continuous monitoring of a product's safety, effectiveness, quality and performance after approval and market launch.
India's post-market safety ecosystem is becoming more structured.
India's post-market safety system is shaped by CDSCO, the Indian Pharmacopoeia Commission, PvPI and, for medical devices, the Materiovigilance Programme of India.
What this means for sponsors
Companies need more than a document writer. They need a post-market operating system that connects safety intake, clinical sites, regulatory documentation, trained teams, patient follow-up and audit-ready archives.
- ✓PSUR calendars should be tracked and not handled at the last minute.
- ✓Adverse events should be captured, followed up and classified through a defined workflow.
- ✓Medical-device complaints and product quality complaints should not remain informal field notes.
- ✓Real-world data should be collected in a way that supports evidence, not just compliance.
Most companies have post-market information. They do not have post-market intelligence.
Field teams hear complaints. Doctors mention tolerability issues. Patients report symptoms. Distributors notice quality concerns. But without a system, important signals remain scattered.
A practical six-layer model for post-market safety control.
Cliorbit's PMS approach is designed to turn field-level product information into documented safety evidence that sponsors can review, act on and archive.
Post-marketing surveillance services Cliorbit can support.
Each service is designed around practical implementation: what data must be captured, who must capture it, how it should be reviewed and what documentation must exist later.
1. Pharmacovigilance system setup for MAHs
For companies that need a defined safety function but do not have a mature internal PV department. For deeper PV support, visit Cliorbit's pharmacovigilance service in India.
- PV SOPs and case-intake workflows
- Responsibility matrix and escalation route
- Training records and quality checks
- Audit-ready trackers and safety logs
2. Adverse event and ADR reporting support
For capturing, documenting and organizing adverse event information from real-world sources.
- Case documentation and follow-up
- Seriousness and expectedness review support
- Source-data and reporter clarification
- Submission-ready case file support
3. PSUR preparation support
For aggregate safety review, reporting interval tracking and benefit-risk documentation. When sponsors need structured narratives, CSR-style summaries or regulatory documents, Cliorbit's medical writing service can support the documentation layer.
- PSUR calendar tracking
- Safety data compilation
- Exposure and cumulative summary support
- Signal and benefit-risk narrative support
4. Phase IV clinical trial support
For post-approval studies related to the approved product, indication, safety or effectiveness question. Sponsors can also explore Cliorbit's clinical research support in Mumbai and IEC/IRB support for study startup and ethics documentation.
- Protocol and feasibility support
- Site and investigator coordination
- Ethics committee documentation
- Recruitment, follow-up and closeout support
5. Observational PMS studies
For tracking safety, tolerability, prescribing patterns and outcomes in routine care.
- Study design and CRF development
- Non-interventional data collection model
- Patient follow-up and site training
- Real-world outcomes documentation
6. Patient registry and real-world evidence support
For structured long-term follow-up and evidence generation beyond spontaneous reports.
- Product, disease or exposure registries
- Demographic and comorbidity capture
- Outcome and adherence tracking
- RWE summary and study documentation
7. Medical device PMS and materiovigilance support
For device companies that need complaint tracking and adverse event documentation.
- Device complaint logs
- MDAE documentation support
- User and hospital follow-up
- Field-safety and CAPA documentation
8. Nutraceutical safety monitoring
For nutraceutical and wellness brands that need structured consumer safety and tolerability evidence.
- Product-use surveys
- Consumer feedback capture
- Physician feedback programs
- Complaint tracking and tolerability summaries
9. Signal review and risk documentation
For sponsors that need to convert repeated cases and complaints into risk-review documentation.
- Case cluster review
- Trend and pattern documentation
- Risk summary and CAPA input
- Label and risk communication support
10. PMS training and compliance documentation
For creating internal awareness and documented proof that teams know what to report.
- Field-team AE awareness training
- Site and coordinator training
- SOP acknowledgement records
- Training attendance and version control
PSUR support should begin with the clock, not the document.
A strong PSUR process starts by understanding the approval date, marketing date, reporting interval, patient exposure, safety data sources and internal review responsibilities.
Educational note: CDSCO's post-marketing guidance includes PSUR and pharmacovigilance requirements for Marketing Authorization Holders. Timelines and applicability should be confirmed for the specific product and current regulatory status.
Not every post-market question needs the same study design.
Cliorbit helps sponsors choose a practical pathway based on the product category, regulatory requirement, safety question, available data and operational feasibility.
| Business or safety question | Best-fit PMS approach | What it can answer |
|---|---|---|
| Are doctors seeing tolerability problems after launch? | Physician feedback program or observational PMS study | Common symptoms, dropout reasons, concomitant medicines and patient groups needing closer monitoring. |
| Is a serious event potentially related to the product? | AE/ADR case assessment and follow-up workflow | Seriousness, causality, expectedness, missing information and regulatory relevance. |
| Does the product need formal post-approval evidence? | Phase IV or PMS observational study | Long-term safety, effectiveness, special population use, prescribing pattern and outcomes under approved conditions. |
| Are repeated complaints indicating a product quality or use issue? | Complaint trending and risk documentation | Complaint clusters, device/user handling issues, batch-related concerns and CAPA triggers. |
| Do we need long-term patient follow-up? | Patient registry or exposure registry | Real-world safety, outcomes, adherence, discontinuation, comorbidities and long-term product experience. |
| Are we ready for inspection or sponsor audit? | PMS readiness review | SOP gaps, missing trackers, training records, PSUR status, case logs and archive quality. |
What should exist inside a mature PMS file?
This is the information gap most companies miss. A PMS system is not only a report; it is a documented chain of evidence.
| Evidence area | What should be documented | Why it matters |
|---|---|---|
| Product and approval profile | Approval status, indication, dosage/use, market launch status, product category and safety concerns known at launch. | Defines what should be monitored and how the PSUR/PMS calendar is interpreted. |
| Safety intake route | Email, phone, field-team route, physician reporting route, patient reporting route and escalation owner. | Prevents safety information from staying informal or getting lost. |
| Case management log | Case ID, reporter, product, event, seriousness, expectedness, follow-up status, closure status and source file. | Creates traceability for AE/ADR review and audit readiness. |
| Follow-up trail | What information was requested, from whom, when, what was received and what remains missing. | Shows active safety management rather than passive record keeping. |
| Exposure data | Estimated units sold, patients exposed, prescriptions, batches, study participants or registry patients. | Helps interpret whether events are isolated or proportionate to exposure. |
| Signal and trend review | Repeated events, severity pattern, population pattern, time-to-onset, dechallenge/rechallenge, complaint trend and reviewer conclusion. | Turns raw cases into safety intelligence. |
| Training records | Who was trained, training date, topic, version, trainer and acknowledgement. | Proves that teams knew how to identify and report safety events. |
| Archive and version control | Final files, draft versions, review notes, approvals, query responses and supporting documents. | Allows the sponsor to reconstruct decisions later. |
PMS becomes stronger when data sources are planned before launch.
Many companies wait for adverse events to arrive. Cliorbit helps sponsors actively define where post-market safety information will come from.
Are you truly post-market ready?
A company is post-market ready only when it can answer these questions clearly and produce evidence for each answer.
Do we have a defined adverse event reporting route?
Without a reporting route, field-level safety information can disappear.
Do doctors, sites and field teams know what to report?
Many events are missed because teams do not understand reportability.
Do we know our PSUR due dates?
Missed timelines create avoidable regulatory pressure.
Do we track patient exposure?
Exposure data helps interpret safety frequency and risk patterns.
Do we maintain follow-up trails?
Incomplete cases weaken causality and benefit-risk assessment.
Do we monitor product complaints and quality issues?
Quality complaints may connect to safety risks or use errors.
Do we review repeated events for signals?
Signal detection begins with pattern recognition.
Can we produce records during inspection?
If it is not documented, it is difficult to prove.
Built for sponsors, MAHs, CROs, device companies and healthcare brands.
Cliorbit can work as a focused India execution partner for post-market safety, study coordination and real-world evidence generation.
| Company type | Common gap | Cliorbit support |
|---|---|---|
| Pharma MAH | PSUR calendar, ADR reporting and PV workflow are not mature. | PSUR support, AE workflow, PV SOPs, safety logs and audit-ready documentation. |
| Biotech sponsor | Needs post-approval safety evidence and site-level India execution. | Phase IV, registry design, site feasibility, investigator coordination and RWE support. |
| Nutraceutical brand | Consumer feedback and tolerability reports are informal. | Post-use monitoring, physician feedback, complaint logs and structured safety reports. |
| Medical-device company | Device complaints and adverse events are not organized into PMS evidence. | Complaint tracking, MDAE documentation, hospital follow-up and materiovigilance support. |
| CRO or global sponsor | Needs India-based operational support for post-approval studies. | Site coordination, patient follow-up, data collection and study documentation. |
| Hospital or investigator site | Needs structured participation in PMS or registry programs. | Site training, patient workflow, documentation support and study coordination. |
What Cliorbit can deliver
Clear, practical outputs that help sponsors show control over post-market safety and evidence generation.
| Service area | Possible outputs |
|---|---|
| PMS system setup | SOPs, workflow, responsibility matrix, reporting channels, trackers and training logs. |
| AE/ADR management | Case logs, follow-up forms, case narratives, seriousness assessment and source review notes. |
| PSUR support | PSUR calendar, safety data compilation, cumulative review, signal discussion and benefit-risk summary. |
| Phase IV study | Protocol support, site feasibility, EC documentation, recruitment coordination and study closeout files. |
| Observational PMS | Study design, CRF, site training, data collection model, follow-up plan and final report support. |
| Registry support | Registry structure, patient follow-up model, exposure tracking, outcome capture and RWE summary. |
| Medical device PMS | Complaint log, MDAE documentation, field follow-up records and device-event classification support. |
| Audit readiness | Master file, trackers, archive structure, training evidence and inspection-support folders. |
A PMS program should survive questions, audits and time.
A good post-market system is not only about creating a report today. It is about making sure every safety decision can be understood months or years later.
What weak PMS looks like
- !Field teams verbally share complaints without a central log.
- !PSUR data is collected only near the deadline.
- !Training is given informally without attendance or version records.
- !Repeated events are not reviewed for trends or signal value.
What Cliorbit helps build
- ✓Defined AE intake, triage, follow-up and closure process.
- ✓PSUR calendar, source tracker and data lock discipline.
- ✓Training logs, SOP acknowledgement and inspection folders.
- ✓Signal review notes, benefit-risk summaries and action records.
Why India is a strong market for PMS and real-world evidence
India offers a large and diverse patient population, multi-specialty hospital access, varied prescribing behaviour, high disease burden across therapeutic areas and a growing safety-reporting ecosystem.
Real-world use across age groups, comorbidities, geographies and treatment settings.
Hospitals and investigators across therapeutic areas can support post-market data collection.
India can support PMS, registries and observational studies at practical operational cost.
PvPI and MvPI have increased focus on patient-safety reporting and post-market monitoring.
Not only document writing. Complete India post-market execution support.
Cliorbit is built around clinical research operations in India. We understand hospitals, investigators, ethics committee documentation, patient follow-up, sponsor expectations and practical site-level challenges. Our PMS work connects naturally with pharmacovigilance, clinical research operations, medical writing and IEC/IRB coordination.
- ✓Clinical site and investigator coordination across India.
- ✓PMS, Phase IV and observational study support.
- ✓Post-market safety workflows for pharma, devices and nutraceuticals.
- ✓Registry and real-world evidence data collection support.
- ✓Audit-ready safety logs, trackers and documentation discipline.
Important PMS terms explained simply
This section helps visitors understand the language used in post-market safety discussions.
| Term | Simple meaning |
|---|---|
| AE | Adverse Event: any unwanted medical occurrence after product use, whether or not it is proven to be caused by the product. |
| ADR | Adverse Drug Reaction: a harmful and unintended response where a relationship with the product is suspected. |
| ICSR | Individual Case Safety Report: a structured safety case for one patient/event report. |
| PSUR | Periodic Safety Update Report: an aggregate safety report covering a defined reporting interval. |
| Signal | Information suggesting a possible new safety concern or new aspect of a known risk. |
| Causality | The assessment of how likely it is that the product contributed to the event. |
| Dechallenge | Whether the event improved after stopping the product. |
| Rechallenge | Whether the event came back after the product was restarted. |
| RWE | Real-World Evidence: evidence generated from routine clinical practice, registries, observational studies or other real-world data sources. |
Build a stronger post-market safety system in India.
If your product is already approved, marketed or entering post-launch monitoring, Cliorbit can help you design the right PMS pathway — from PSUR support and AE reporting to Phase IV studies, registries, device PMS and real-world evidence. You can also connect this with our pharmacovigilance, medical writing, clinical research and IEC/IRB support.
Frequently Asked Questions
What is post-marketing surveillance?
Post-marketing surveillance is the continuous monitoring of a product's safety, effectiveness, quality and real-world performance after approval and market launch.
What is the difference between PMS and pharmacovigilance?
Pharmacovigilance mainly focuses on adverse effects and medicine-related safety problems. PMS is broader and may include pharmacovigilance, Phase IV studies, registries, real-world evidence, product complaints, device vigilance and risk-management documentation. Learn more on Cliorbit's pharmacovigilance service page.
Does Cliorbit support PSUR preparation?
Yes. Cliorbit supports PSUR calendar tracking, safety data compilation, patient exposure estimation, cumulative safety summaries, signal discussion, benefit-risk narrative support and submission-ready documentation.
Can Cliorbit conduct Phase IV and observational PMS studies?
Yes. Cliorbit supports Phase IV and observational PMS studies through protocol support, site feasibility, investigator coordination, ethics committee documentation, patient follow-up, data collection and final report support.
Does Cliorbit support medical-device PMS?
Yes. Cliorbit supports device complaint tracking, medical-device adverse event documentation, hospital/user follow-up, field-safety documentation and materiovigilance-ready records.
Can nutraceutical companies use PMS services?
Yes. Nutraceutical companies can use PMS support for consumer safety monitoring, tolerability studies, physician feedback, product-use surveys, complaint tracking and post-use evidence generation.
What should a sponsor prepare before starting PMS?
A sponsor should prepare the approval and marketing status, product profile, known risks, patient exposure estimate, available safety data, complaint history, target sites, reporting owners and existing SOPs or trackers.
Which Cliorbit services are connected with PMS?
PMS is closely connected with pharmacovigilance, clinical research operations, medical writing and IEC/IRB support.
Regulatory reference links included for reader education: CDSCO, CDSCO pharmacovigilance/PSUR guidance, WHO India PvPI note and NHSRC/MvPI resource. This page is designed for knowledge and service education; final regulatory interpretation should be confirmed for the specific product category, approval status and current applicable rules.
