Domain
Where are we?
Pharma, biotech and medical device companies (sponsors), CROs and CDMOs, investigator sites and ethics committees, distributors and pharmacies — regulated by the FDA, EMA and, in India, CDSCO.
How the healthcare — life sciences business actually flows
Pharma, biotech and medical devices — how a medicine travels from the lab to the patient: trials, approval, GMP manufacturing, supply and safety. Every session in this track hangs off this one flow, so you always know which part of the business you are looking at.
- Discover & preclinical
- Clinical trials
- Regulatory approval
- Manufacture (GMP)
- Supply & commercial
- Safety (PV)
The nine layers of the Healthcare — Life Sciences domain
Every BDC track answers the same nine questions in the same order, so knowledge from one domain transfers to the next. Here is what each layer looks like in Healthcare — Life Sciences.
Business
How does it make money?
Invest for a decade, earn it back under patent protection. KPIs: pipeline value and attrition, trial cycle times, enrolment rate, right-first-time batches, batch release time, OTIF and on-time safety reporting.
Process
How does the work flow?
Discover → Preclinical → Clinical trials (phases 1–4) → Regulatory approval → Manufacture & QA release → Supply & commercial → Pharmacovigilance.
System
Which applications run it?
ELN & LIMS, CTMS, EDC, IRT, eCOA, eTMF, RIM & eCTD publishing, QMS, MES & ERP, serialisation, the safety database (Argus, LifeSphere), CRM and master data.
Data
What information matters?
Protocol, subject, visit and CRF; batch record, deviation and CAPA; the adverse-event case — coded with MedDRA and WHODrug; products identified by GTIN, lot and serial number.
Integration
How do systems talk?
CDISC CDASH, SDTM, ADaM and define.xml, E2B R3 safety messages to FAERS and PvPI, eCTD submissions, IDMP, GS1 barcodes and EPCIS events, HL7 FHIR.
Transaction
Follow one, end to end.
Protocol approved → Sites activated → Patient consented & randomised → Visits in EDC → Queries resolved → Database lock → SDTM / ADaM → Clinical study report → eCTD module 5
Testing
How do we prove it works?
CSV / CSA validation (IQ, OQ, PQ), Part 11 audit trails and e-signatures, edit checks, randomisation and blinding, safety day-zero and 15-day clocks, batch limits and QA release, serialisation aggregation and data migration.
Real-world scenario
What happens on a live project?
A new site report shows kit numbers next to patient IDs, putting the study's blinding at risk. Trace how it reached production — and design the review that catches it.
Sessions in the Healthcare — Life Sciences track
Ten sessions, one per framework layer, closing with a proctored certification assessment. Session 01 is free for everyone, in English and Telugu, and Session 02 is free with a free account.
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How a medicine travels from the lab bench to the patient — the players, the seven-stage pharma value chain, one clinical trial end to end, the systems and standards behind it, GxP and validation, and what QA must test. With an animation for every stage.
- What life sciences is — pharma, biotech, devices, CROs and CDMOs
- The seven stages of a medicine, discovery to pharmacovigilance
- Inside one clinical trial — protocol to database lock
- Systems, CDISC / E2B / eCTD standards and GxP rules
- Validation (CSV / CSA) and the QA view
- GxP
- EDC
- eCTD
- E2B
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HLS-S02
How a Life Sciences Company Makes Money
UpcomingPatents, pipelines and launches — and the numbers pharma leadership watches every quarter.
- Ten to fifteen years from discovery to approval
- Patent life, exclusivity and the generic cliff
- Branded, generic and biosimilar business models
- CROs and CDMOs — the service side of the industry
- Cycle times, right first time and OTIF
- Pipeline
- Patent
- Generic
- CDMO
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HLS-S03
Molecule to Market: The Life Sciences Process
UpcomingDiscover, test, trial, approve, make, supply and watch safety — and the controls at each step.
- Discovery and preclinical under GLP
- Clinical trial phases 1 to 4 under GCP
- IND, NDA / BLA / ANDA and CDSCO approval
- Manufacture and QA batch release under GMP
- Distribution, serialisation and pharmacovigilance
- GLP
- GCP
- GMP
- GVP
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HLS-S04
The Life Sciences Systems Landscape
UpcomingELN, LIMS, CTMS, EDC, IRT, eTMF, RIM, QMS, MES, the safety database and CRM — what each one owns.
- Research — ELN and LIMS
- Clinical — CTMS, EDC, IRT, eCOA and eTMF
- Regulatory — RIM and eCTD publishing
- Quality and manufacturing — QMS, MES and ERP
- Safety and commercial — Argus / LifeSphere, CRM and MDM
- CTMS
- EDC
- QMS
- MES
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HLS-S05
Trial, Batch & Safety Data
UpcomingThe records, dictionaries and identifiers that every life sciences system depends on.
- Protocol, subject, visit and CRF
- Batch record, deviation, CAPA and change control
- Adverse-event case — seriousness, causality, day zero
- MedDRA and WHODrug coding
- Product master — GTIN, lot, expiry and serial number
- CRF
- Batch record
- MedDRA
- GTIN
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HLS-S06
CDISC, E2B & eCTD: Life Sciences Integrations
UpcomingHow trial, safety, submission and serialisation data moves between systems — and where it breaks.
- EDC to SDTM and ADaM (CDISC)
- IRT and EDC — subject and kit assignments
- SAE reconciliation — EDC against the safety database
- E2B R3 cases to FAERS and PvPI
- eCTD submissions and EPCIS serial events
- SDTM
- E2B R3
- eCTD
- EPCIS
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HLS-S07
Follow One Clinical Trial, End to End
UpcomingA single trial traced from the protocol to the clinical study report in the submission.
- Protocol, site selection and ethics approval
- Consent, screening and randomisation
- Visits captured in EDC and ePRO
- Monitoring, queries and database lock
- Analysis, the CSR and eCTD module 5
- Protocol
- Randomisation
- Database lock
- CSR
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HLS-S08
Testing Life Sciences Systems
UpcomingValidation, audit trails, blinding, safety clocks and serialisation — and why life sciences values testing so highly.
- CSV and CSA — URS, risk, IQ, OQ and PQ
- 21 CFR Part 11 audit trails and e-signatures
- Edit checks, randomisation and blinding
- Day zero and the 15-day safety clock
- Batch limits, QA release, aggregation and data migration
- CSV
- CSA
- Part 11
- ALCOA+
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HLS-S09
Real-World: The Report That Unblinded a Study
UpcomingA new site report shows kit numbers next to patient IDs — and the study's blinding is suddenly at risk.
- How the report reached production
- Who could work out the treatment arm
- Containment and what to tell the sponsor
- Root cause: no blinding review of new outputs
- The test that would have caught it
- Blinding
- IRT
- Incident
- Prevention
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HLS-S10
Healthcare Life Sciences Certification Assessment
UpcomingThe whole life sciences track in one place — a short recap video, then a proctored online assessment that applies all nine framework layers to a real-world scenario.
- Nine-layer recap of the life sciences domain
- The five things most people get wrong
- 30 questions · 45 minutes · 60% to pass
- Webcam-proctored, one question at a time
- Certificate with a verifiable ID
- Assessment
- Certification
- Proctored
- Nine layers
Healthcare — Life Sciences terms you will hear on every project
The vocabulary that separates someone who can follow a healthcare — life sciences requirements discussion from someone who cannot.
- GxP
- 21 CFR Part 11
- EDC
- eCTD
- E2B
- CAPA
Certified Healthcare — Life Sciences Domain Practitioner — BDC-HLS
Finish the ten sessions, pass the online proctored assessment, and submit a scenario analysis to earn this domain's certificate. Each domain certifies separately.
Step 01
Learn
Watch every session in the Healthcare — Life Sciences track and work through the handbook, framework workbook and test scenario checklist.
Step 02
Assess
Sit the online domain assessment — proctored with webcam on, no copying, no switching tabs and no looking answers up.
Step 03
Certify
Submit a real-world scenario analysis and receive your BDC-HLS certificate.
Enrolment
₹4,000₹6,000
All taxes included · $60 outside India · launch price
One payment unlocks the whole Healthcare — Life Sciences track: all 10 sessions in English and Telugu, every handbook, workbook and deck, the proctored assessment and the BDC-HLS certificate. Session 01 stays free for everyone. Taking more than one domain? Two are ₹10,000 and all seven tracks are ₹20,000 for a year.
Common questions
What is healthcare — life sciences domain knowledge, and why do QA and BA roles need it?
Pharma, biotech and medical devices — how a medicine travels from the lab to the patient: trials, approval, GMP manufacturing, supply and safety. Invest for a decade, earn it back under patent protection. KPIs: pipeline value and attrition, trial cycle times, enrolment rate, right-first-time batches, batch release time, OTIF and on-time safety reporting. Without that picture, testers write cases against screens instead of against the business, requirements get read literally, and defects that matter most are the ones nobody thought to look for. This track gives you the business first and the systems second.
What does the Healthcare — Life Sciences track cover?
Ten sessions following the nine-layer BDC framework: 01 Healthcare — Life Sciences at a Glance; 02 How a Life Sciences Company Makes Money; 03 Molecule to Market: The Life Sciences Process; 04 The Life Sciences Systems Landscape; 05 Trial, Batch & Safety Data; 06 CDISC, E2B & eCTD: Life Sciences Integrations; 07 Follow One Clinical Trial, End to End; 08 Testing Life Sciences Systems; 09 Real-World: The Report That Unblinded a Study; closing with the Healthcare Life Sciences Certification Assessment.
Is the Healthcare — Life Sciences training free?
Session 01, the "at a glance" overview, is free for everyone in both English and Telugu. Session 02 is free too once you create a free account, with its slides and notes. The remaining sessions, materials, assessment and certificate unlock when you enrol for this domain's certification, which costs ₹4,000, or $60 outside India — a launch price, down from ₹6,000. It is one payment for lifetime access to this domain — there is no subscription.
Are the sessions available in Telugu?
The website and the main sessions are in English. Separate Telugu explanation videos are published on the YouTube channel for released sessions, in conversational Telugu with technical terms left in English.
Who teaches these sessions?
Chandramouli Pasumarthy, Director of Quality Engineering and Delivery with 20+ years in the IT industry, leading QA and delivery for enterprise programmes across healthcare, retail, financial services, government and logistics.
Start the Healthcare — Life Sciences track
Session 01 is free, and a free account opens Session 02 too. Create one to keep your progress, download the summary notes, and get each new session as it releases.