Cadila CRO

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CADILA CRO
Clinical Research
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Objective Goals
Our Objective Taking life sciences to new
horizons through innovative research, high
quality, ethics commitment.

• Our Goal
• To be a leading CRO in the world using committed
  resources to achieve 100 quality and
  compliance with good science, accurate
  techniques, prompt delivery and utmost Customer
  satisfaction.

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Cadila CRO Services

• Pre-Clinical and Toxicology studies.
• Bio-availability / Bio-equivalence studies.
• Bio-analysis
• Clinical Trial Management Phase II IV
• Data Management and Biostatistics
• Medical Writing

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Salient Features of Existing Animal Unit.

• Total Area 518 Sq.m with 8 Animal rooms 1
  Laboratory room.
• Double corridor facility.
• Automated Illumination 12 hr. lighting in 24
  hours cycle.
• 100 exhaust facility. No recirculation of air.
• Animal house walls painted with epoxy non-toxic
  washable paints.
• Species Propagated in-house breeding unit
• NZW Rabbits, Wistar Rats, Guinea Pigs,
  Swiss Albino Mice, C57BL/6ByJ Mice, F1 C57 DBA,
  DBA/2J Mice, BALB/C Mice
• Accreditations
• DSIR, Govt. of India.
• b. ISO 9001 and ISO 14001.
• Animal House is Registered With CPCSEA

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Pre Clinical and Toxicology Services

• We have completed more than 700 studies and
  developed following capabilities in
  Toxicological studies.
• Single dose or multiple dose in single day, acute
  toxicity, acute eye irritation and acute dermal
  irritation
• Repeated Dose, sub-acute (28 Days) and
  sub-chronic (90 Days)
• Special studies, genotoxicity, reproduction
  toxicity and toxicokinetics
• Allergenicity, Guinea pig maximization test
  (GPMT) and Mouse ear swelling test (MEST)
• In Vivo Efficacy Studies, Antifertility test,
  Antidiabetic, Analgesics, Anti-hyper lipidemic
  and Pharmacokinetics.

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Pre Clinical Expertise

• Special studies
• Genotoxicity
• Micro Nucleus Test (MNT)
• Reproduction toxicity
• One generation
• Toxicokinetics
• Allergenicity
• Guinea pig maximization test (GPMT)
• Mouse ear swelling test (MEST)
• In Vivo Efficacy Studies
  
• Antifertility test.
• Antidiabetic.
• Analgesics.
• Anti-hyper lipidemic.
• Pharmacokinetics.

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In House Pathology Laboratory

• The pathology laboratory is equipped with
• HITACHI-902 - biochemistry analyzer
• ADVIA-120 - haematology analyser
• CLINITEK STATUS - urine analyser
• Electrolyte analyser
• External quality control
• programme for biochemistry.
• Well equipped histopathology
• laboratory.

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Capabilities
Clinical Pharmacology Unit

• Two separate identical 45 bedded units (total 90
  beds) with well equipped ICUs.
• Volunteer data pool of approx 5,500 healthy
  volunteers including 500 female volunteers and
  400 geriatric volunteers database.

• Protocol development and Study designing.
• Conduct of a range of BA/ BE studies
• Single dose /multiple dose
  Fasting /Fed / Steady state studies.
• Dose proportionality and
• Therapeutic equivalence studies.
• Open-labeled / blinded studies.

Successfully completed approx. 180 studies, which
includes Intravenous Anesthetic BE study, Early
phase exploratory vaccine trial, Drug
interaction, female volunteers, and more.
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Experience in BE (conducted more than 180 BE
studies)

• Intravenous Anesthetic bioequivalence study,
  which involved Frequent sampling every 2 minutes
  interval from each subjects and Critical care of
  each subject during AE by Physician, Anesthetics
  and emergency equipments and drugs.
• Early phase exploratory vaccine trial on healthy
  volunteers.
• Conducted concurrently male and female volunteer
  studies
• Bioequivalence studies on large numbers of
  volunteers, n80
• Drug-drug interaction studies
• Drug-Drug interaction in new Fixed Dose
  Combination (FDC) compared with individual
  reference products
• A novel POLYCAP (First time in the world a Fixed
  Dose Combination containing Atenolol, Ramipril,
  Hydrochlorothiazide, Simvastatin and enteric
  coated Aspirin) compared with its single
  individual reference products to evaluate gain or
  loss in bio-availability and drug-drug
  interaction in five different two period two way
  cross over studies.
• Result of this study was very well co-related
  with result of TIPS (The India Polycap study)
  study and has approved the concept of POLYCAP
• Anti-retroviral and Anti-tubercular drug-drug
  interaction studies.

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Bio-Analytical Services

• Features
• Well equipped with latest detection
  methodologies.
• Instruments LC-MS/MS, Automated HPLCs, UPLCs,
  Deep freezers, Refrigerated Centrifuges, N2
  Evaporators,
• Plasma SPE extractors,
• Milli Q-Water system.
• Team of 20 well qualified and
• experienced scientists.
• A list of 80 validated methods
• which are rugged and reproducible.

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Your advantage on Bio equivalence Project
Timelines
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CRO Regulatory Accomplishments

• Accreditations Certifications
• DCGI certification for the BA/BE centre.
• Audited approved by WHO Geneva
• Approved BA/BE facility by MoH, Turkey.
• MCC South Africa - Certification for the
  Dossier submitted..
• MHRA - Dossier submitted accepted.
• TGA Australia Dossier submitted accepted.
• ANVISA, Brazil.

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Clinical Research ( Phase II IV )

• Cadila CRO offers complete package for conducting
  Phase II-IV Clinical Trials.
• Unique Features
• GCP trained Clinical Trial management team.
• Robust experience in various therapeutic areas.
• Extensive network of hospitals and medical
  institutes through out India.
• Large database of investigators
• Proficient Patient Recruitment strategy.
• Timely and scientific delivery of projects.

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Clinical Trial Services

• Medical Writing Protocol Development
• Protocol Development, designing of Screening form
  CRF
• Expert review reports of Safety data.
• Statistical Analysis Plan and Report.
• Regulatory Support.
• Site Development Management
• Investigator and Site Identification, selection,
  initiation, monitoring contracts with
  Investigators and site close outs
• Site staff and Investigators training
• Randomization, repackaging, coding labeling of
  Investigational Products.
• Site Supplies.
• Medical monitoring Query management.
• Project Management Site Monitoring
• Clinical development plan.
• Steering committee meetings.
• Training Development.
• Quality systems Implementation.
• GCP Audits at Investigators Site.

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Therapeutic Expertise

• Oncology
• Endocrinology
• Anti-infective
• Urology
• Cardiovascular
• The Team also has experience in working in
  the following Therapeutic areas
• GI
• Rheumatology
• Immunology
• Neurology
• Dermatology
• Womens healthcare
• Recently we had signed a Joint Venture with
  an international vaccine company which has a
  number of molecules in pipeline, for that we will
  be conducting a series of vaccine trials

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Data Management Biostatistics

• Soft wares
• WinNonlin Professional Version 5.0.1 (Pharsight
  Corporation, USA)
• SAS Statistical Software Version 9.1.3 (SAS
  Institute Inc., USA )
• Automation of all trial activities by using
  Oracle Clinical 4.5.1 and
• Thesaurus Management System 4.5.2
• Related Services
• Sample size determination, CRF designing, Patient
  Randomization, Query generation, resolution and
  tracking , Data Analysis, Transfer and Archive
  and Generation of statistical report.
• Offers protocol review and Preparation of
  statistical Analysis Plan and conduct statistical
  analysis for BA/BE, Preclinical and Clinical
  Trials
• Compliance ICH GCP, Companys SOPs and
  21 CFR part 11

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Oncology Case Study on Efficient Patient
Recruitment
CT/V01/12/09
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Current Clinical Trials Experiences Status
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Why Cadila CRO

• Because we bring together
• State of the art infrastructure.
• Highly competent team led by globally experienced
  and renowned scientists to ensure validity of all
  scientific work.
• High confidentiality standards.
• Utmost professionalism harmonizing with ethical
  practices.
• Strict adherence to GCP,GLP and in-house SOPs.
• Rapid turn-around time.
• Strong commitment to responsiveness and timely
  delivery.
• Expert review resolution of queries.
• Excellent project management practices/tools
  backed by dynamic and creative project tracking
  system.
• In depth Regulatory knowledge, support
  expertise.
• Flexibility and Multi specialty.
• Large pool of volunteer databank enabling fast
  selection recruitment.
• Respect to Clients IPR
• Excellent track record.
  

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Your Reliable Indian Partner for global contract
research requirements. Shruti Shukla - Vice
President, Cadila CRO shruti.shukla_at_cadilapharma.c
o.in