PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining deep expertise with advanced solutions to streamline clinical trials, we enable biotech and pharma companies to reach critical milestones with quality results. Our support covers all phases.

Our support covers all phases, starting from early Phase I First-in-Human and Safety Studies to Phase II Proof-of-Concept and Dose Optimization. Additionally, we provide support for Phase III Pivotal Registration Studies, Phase IV Post-Marketing Real-World Evidence, and Investigator-Initiated Trials (IITs).

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PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining deep expertise with advanced solutions to streamline clinical trials, we enable biotech and pharma companies to reach critical milestones with quality results. Our support covers all phases.

Our support covers all phases, starting from early Phase I First-in-Human and Safety Studies to Phase II Proof-of-Concept and Dose Optimization. Additionally, we provide support for Phase III Pivotal Registration Studies, Phase IV Post-Marketing Real-World Evidence, and Investigator-Initiated Trials (IITs).

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PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining deep expertise with advanced solutions to streamline clinical trials, we enable biotech and pharma companies to reach critical milestones with quality results. Our support covers all phases.

Our support covers all phases, starting from early Phase I First-in-Human and Safety Studies to Phase II Proof-of-Concept and Dose Optimization. Additionally, we provide support for Phase III Pivotal Registration Studies, Phase IV Post-Marketing Real-World Evidence, and Investigator-Initiated Trials (IITs).

  • Protocol Synopsis
  • Full Study Protocol
  • Informed Consent ISF
  • Study Trainings
  • CTA application & submission management for REC/IRB/IEC and regulators filings (IND, CTA, IMPD, NDS, MAA, ANDA)
  • eCTD preparation and global dossier publishing
  • EMA, FDA and competent authorities interaction
  • Safety Events Reporting (SAE, SUSAR)
  • Periodic Safety Reports (ASR, DSUR, PSUR)
  • Safety Management Plan
  • 24/7 Medical Monitoring
  • Pre-Market PV System Set-up
  • PV Market Operations >5 Years
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • Project Management Oversight
  • Vendor Management
  • Study Logistics & Labelling
  • Investigator Payments
  • eCRF design + EDC setup
  • Data cleaning
  • Query management
  • Database look
  • Protocol Synopsis
  • Full Study Protocol
  • Informed Consent Forms
  • Clinical Study Report
  • Sample Size Calculation
  • Randomization Schedules
  • Statistical Programming and Analysis
  • Statistical Analysis Report
  • real-time data cleaning + query resolution
  • Biostatistical analysis (SAP, TLFs)

 

  • Protocol Synopsis
  • Full Study Protocol
  • Informed Consent ISF
  • Study Trainings
  • CTA application & submission management for REC/IRB/IEC and regulators filings (IND, CTA, IMPD, NDS, MAA, ANDA)
  • eCTD preparation and global dossier publishing
  • EMA, FDA and competent authorities interaction
  • Safety Events Reporting (SAE, SUSAR)
  • Periodic Safety Reports (ASR, DSUR, PSUR)
  • Safety Management Plan
  • 24/7 Medical Monitoring
  • Pre-Market PV System Set-up
  • PV Market Operations >5 Years
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • Project Management Oversight
  • Vendor Management
  • Study Logistics & Labelling
  • Investigator Payments
  • eCRF design + EDC setup
  • Data cleaning
  • Query management
  • Database look
  • Protocol Synopsis
  • Full Study Protocol
  • Informed Consent Forms
  • Clinical Study Report
  • Sample Size Calculation
  • Randomization Schedules
  • Statistical Programming and Analysis
  • Statistical Analysis Report
  • real-time data cleaning + query resolution
  • Biostatistical analysis (SAP, TLFs)

 

Hospital Integrated Recruitment

benefits of shankus hospitals as a trial site

  • 6000+ monthly OPDs, 2000+ Patients treated monthly
  • Large hospital databases: daily new patient flow
  • Physician referral networks + dedicated recruitment managers
  • Feasibility-driver, Tailor-made recruitment strategies
  • Ethics Committee (EC) – 30-60 days
  • COSCO/DCG approval: up to 90 working days
  • CTRI registration: before first patient in
  • Import license (if applicable): 15-30 days with parallel EC + COSCO submissions, study start can be achieved in 3 to 4 months 
  • 50 acre campus, 60 hospitals beds, 25 ICU beds
  • 5 high-end Ots, 24/7 Emergency & Trauma
  • Strong protocol development & feasibility expertise
  • In-house Pathology, Radiology, Pharmacy, Ambulance
  • Ultra-modern CT & full time doctors on site 
  • Phases I-VI, including PK/PD and investigator: initiated Trials
  • End-to-end support: regulatory, project management, study coordination
  • Strong protocol development & feasibility expertise
  • Experience study team (PI, Co-I Medical Officer, CRA and nurse) to manage the study
  • Conducted studies for DOG, USDSA, FMA submissions
  • 90% to 95% patient retention ratio in all clinical units

Hospital Integrated Recruitment

benefits of shankus hospitals as a trial site

  • 6000+ monthly OPDs, 2000+ Patients treated monthly
  • Large hospital databases: daily new patient flow
  • Physician referral networks + dedicated recruitment managers
  • Feasibility-driver, Tailor-made recruitment strategies
  • Ethics Committee (EC) – 30-60 days
  • COSCO/DCG approval: up to 90 working days
  • CTRI registration: before first patient in
  • Import license (if applicable): 15-30 days with parallel EC + COSCO submissions, study start can be achieved in 3 to 4 months 
  • 50 acre campus, 60 hospitals beds, 25 ICU beds
  • 5 high-end Ots, 24/7 Emergency & Trauma
  • Strong protocol development & feasibility expertise
  • In-house Pathology, Radiology, Pharmacy, Ambulance
  • Ultra-modern CT & full time doctors on site 
  • Phases I-VI, including PK/PD and investigator: initiated Trials
  • End-to-end support: regulatory, project management, study coordination
  • Strong protocol development & feasibility expertise
  • Experience study team (PI, Co-I Medical Officer, CRA and nurse) to manage the study
  • Conducted studies for DOG, USDSA, FMA submissions
  • 90% to 95% patient retention ratio in all clinical units

Early-Phase & PK/PD

Certifications and accreditations

Integrated Partners for Early Phase PK/PD Studies.

HEMEX and ShankusENEM operate as site-integrated clinical research partners, supporting sponsors in the efficient execution of Early Phase pharmacokinetic (PK) and pharmacodynamic (PD) studies.

Together, HEMEX and ShankusENEM provide a streamlined pathway from protocol activation to first patient dosing, ensuring predictable enrolment timelines and reliable clinical data generation.

This integrated model allows sponsors to conduct PK/PD studies with minimized operational risk, improved recruitment efficiency, and consistent study execution.

Challenges

  • Logistical complexity and fragmented workflows in coordinating dosing, sampling and analysis across CROs, sites, labs
  • Slow patient recruitment in early-phase populations
  • Time-sensitive PK/PD sampling increasing operational pressure
  • Comprehensive BA/BE solution
  • Integrated early-phase trials with ShankusEnem
  • Coordinated workflows and streamlined collaboration between PK/PD site and operational team.

BA/BE Studies

Helping pharmaceutical manufacturers achieve successful US, GCC & global registrations through Swiss-contracted BA/BE and CRO solutions.

HEMEX and Shankus Enem give manufacturers a single, Swiss-contracted partner for bioavailability and bioequivalence studies — built for the reliability and regulatory rigor needed for US, GCC and international registration, backed by a hospital-integrated early-phase unit and a 12,301-volunteer database.

Protocol-to-Dose Pathway

Benefits of
ShankusENEM

Concerns over local CRO quality & consistency
Swiss-contracted oversight backed by 428 completed BE studies

Navigating multiple pathways for export markets (US, GCC, LatAm)
One site certified by FDA, ANVISA, GCC, NPRA & UK MHRA

Disconnected API, formulation, BE/BA & CRO vendors
One integrated group — from API to clinical data

Slow enrolment for BE/BA volunteer studies
12,301-volunteer database with dedicated recruitment managers

 

Clinical & Bioanalytical Infrastructure

  • 108-bed facility · 2-bed ICU
  • 26 beds for female volunteers
  • 15,000 sq ft clinical space
  • 6,000 sq ft bioanalytical lab
  • Advanced LC-MS/MS & ICP-MS
  • 21 CFR Part 11 compliant systems

Proven Experience Across 428 BE Studies

Top areas by volume
Cardiology (81), Endocrinology (60), Gastroenterology (32), Immunology (31), Neurology (29), Oncology (28)

Also covered
Urology, Psychiatry, Dermatology, Neuropsychiatry, Pulmonology, Orthopedic, Respiratory, Gynecology & more

Early-Phase & PK/PD

Certifications and accreditations

Integrated Partners for Early Phase PK/PD Studies.

HEMEX and ShankusENEM operate as site-integrated clinical research partners, supporting sponsors in the efficient execution of Early Phase pharmacokinetic (PK) and pharmacodynamic (PD) studies.

Together, HEMEX and ShankusENEM provide a streamlined pathway from protocol activation to first patient dosing, ensuring predictable enrolment timelines and reliable clinical data generation.

This integrated model allows sponsors to conduct PK/PD studies with minimized operational risk, improved recruitment efficiency, and consistent study execution.

Challenges

  • Logistical complexity and fragmented workflows in coordinating dosing, sampling and analysis across CROs, sites, labs
  • Slow patient recruitment in early-phase populations
  • Time-sensitive PK/PD sampling increasing operational pressure
  • Comprehensive BA/BE solution
  • Integrated early-phase trials with ShankusEnem
  • Coordinated workflows and streamlined collaboration between PK/PD site and operational team.

BA/BE Studies

Helping pharmaceutical manufacturers achieve successful US, GCC & global registrations through Swiss-contracted BA/BE and CRO solutions.

HEMEX and Shankus Enem give manufacturers a single, Swiss-contracted partner for bioavailability and bioequivalence studies — built for the reliability and regulatory rigor needed for US, GCC and international registration, backed by a hospital-integrated early-phase unit and a 12,301-volunteer database.

Protocol-to-Dose Pathway

Benefits of
ShankusENEM

Concerns over local CRO quality & consistency
Swiss-contracted oversight backed by 428 completed BE studies

Navigating multiple pathways for export markets (US, GCC, LatAm)
One site certified by FDA, ANVISA, GCC, NPRA & UK MHRA

Disconnected API, formulation, BE/BA & CRO vendors
One integrated group — from API to clinical data

Slow enrolment for BE/BA volunteer studies
12,301-volunteer database with dedicated recruitment managers

 

Clinical & Bioanalytical Infrastructure

  • 108-bed facility · 2-bed ICU
  • 26 beds for female volunteers
  • 15,000 sq ft clinical space
  • 6,000 sq ft bioanalytical lab
  • Advanced LC-MS/MS & ICP-MS
  • 21 CFR Part 11 compliant systems

Proven Experience Across 428 BE Studies

Top areas by volume
Cardiology (81), Endocrinology (60), Gastroenterology (32), Immunology (31), Neurology (29), Oncology (28)

Also covered
Urology, Psychiatry, Dermatology, Neuropsychiatry, Pulmonology, Orthopedic, Respiratory, Gynecology & more

Request more information

Your privacy is important to us. By submitting this form you are agreeing to be bound by HEMEX legal terms and privacy policy.

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations

Request more information

Your privacy is important to us. By submitting this form you are agreeing to be bound by HEMEX legal terms and privacy policy.

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations

Your privacy is important to us. By submitting this form you are agreeing to be bound by HEMEX legal terms and privacy policy.