services

Our Services
Clinical Development
Clinical Development Clinical Development
  • Project Management
  • Clinical Trial Supply Management
  • Site Management
  • Clinical Monitoring
  • Clinical Trial Monitoring
  • Vendor Management
  • Clinical Data Management
    Clinical Data Management
  • Database Design and Validation
  • Data Entry Screens
  • Query Generation and Resolution
  • Adverse Event and Concomitant Medication Coding
  • Database Status Updates
  • Remote Data Entry (RDE)CRF Log and Tracking
  • CRF Review
  • Correction Processing
  • Data Quality Reviews and control
  • SAS Data base designing
  • Double Data Entry and Verification
  • Clinical Data Review
  • Audit Trail Generation (Per 21CFR Part 11)
  • Database Lock and Archiving
  • Report Generation (Business Objects and Crystal Reports)
  • Compliance with 21 CFR Part 11
  • Regulatory Affairs
    Regulatory Affairs

      Dossier compilation as per:

    • Asean Common Technical Dossier (ACTD) Guidelines
    • Common Technical Dossier (CTD) Guidelines
    • Drug Master File (DMF)

      Drafts data for:

    • BMR, MFR
    • Process Validation
    • Analytical Validation
    • Stability Study reports
    • Dissolution profile
    • Certificate of analysis and related reports

      Compilation of:

    • Justification for fixed dose combination
    • Prepare Periodic Safety Update report (PSUR)

      Prepare Summary of:

    • Summary of Product Characteristics (SmPC)
    • Patient Information Leaflet (PIL)
    • Label and carton content
    • Product Development

      Overviews (Module 2):

    • Clinical
    • Non Clinical

      Non Clinical Study Reports (Module 4)

      Clinical Study Reports (Module 5)

    Medical Writing
    Medical Writing and Publishing Services
    • NDA, MAA, NDS, PMA
    • Full publishing: Fully compliant electronic or paper deliverable ready to submit to Health Authority
    • Clinical study protocols and reports
    • Clinical study report appendices
    • Case report forms
    • Define/CRT documents
    • Investigator Brochures
    • Publishing services can be full publishing or submission-ready, as best meets the Sponsor's needs
    • IND, IMPD, IDE
    • Briefing/meeting packages
    • Submission ready: Fully compliant electronic document preparation ready for Sponsor to complete full publishing for submission to Health Authority.
    Biostatistics and Programming
    Biostatistics and Programming
    • Statistical inputs for protocol design
    • Sample size calculation
    • Establishing statistical analysis plans
    • Planning and implementing randomization
    • MedDRA® for Adverse Event coding
    • Preparing and analyzing ISS/ISE databases
    • Conducting data mining and exploratory analyses
    • SAS programming for interim and final analysis
    • Providing support for regulatory and advisory meetings
    • SAS PheedIt (21 CFR, Part 11) for data capture and validation for EDC and paper based studies
    • SAS Analytics for statistical analysis
    • Adobe PageMaker for CRF designing
    • WHO-DD for medication coding
    Central Laboratory
    Central Laboratory
    • Provides all necessary materials (sample collection kits, sample storage materials, sample shipping materials and manuals/ instructions)
    • Act as logistics coordinator for both incoming and outgoing shipments
    • Receive samples, reconcile sample data with the protocol requirements and forward the samples to the laboratory for analysis. All queries are communicated with sites and CRAs to prevent delays in result reporting
    • Archive lab data
    • Generate customized result reports accessible online
    • Demographic data, Medical and Medication histories, General Physical Examination and systemic examination, ECG, Chest X-ray, Hematology, Biochemistry, Serology and Urine analysis
    Safety Reporting & pharmacovigilance
    Safety Reporting & pharmacovigilance
    • Set up and maintenance of global safety database
    • Literature search in compliance with regulatory requirements
    • Medical review of case reports
    • Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs.
    • Online coding (MedDRA, WHO DDE) of Adverse Events.
    • Preparation of safety narratives.
    • Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities
    • Preparation and submission of expedited reports to regulatory authorities.
    Pre Clinical Services
    Pre Clinical Services

      LABORATORY SERVICES

    • Toxicology Studies
    • Efficacy Studies
    • Pharmacokinetics
    • Animal studies and Bio assays
    • DMPK
    • Drug Testing Laboratory Services
    • Haematology Parameters Analysis
    • Clinical Chemistry Parameters Analysis

      LABORATORY ANALYTICAL SERVICES

    • Histopathology Services: Tissue Processing, Slide Preparation, Staining
    • Histopathology Consultation: Histopathology Slide Evaluation, Peer Review of Histopathology Slides and Report Preparation
    • Quality Serum and Plasma Services

      LABORATORY ANIMAL SERVICES

    • Rats-Wistar and Sprague-Dawley
    • Mice-Swiss albino, Balb/c and C57
    • Rabbits-Newzealand White
    • Guinea pigs-Dunkin Hartley

    PRECLINICAL SERVICES

    • Dose range finding studies
    • Maximum tolerable dose determination studies
    • Acute toxicity studies
    • 7-day toxicity study
    • Biopharmaceuticals products manufacturers
    • Repeated dose toxicity studies-14-day, 28- day and 90-day
    • Chronic toxicity studies
    • Allergic sensitization
    • Reproductive toxicity studies
    • Anti-diabetic study
    • Anti-obesity study
    • Pharmacokinetics trials
    • Immunization trials
    • Abnormal toxicity study
    • Bio-identity study
    • Hormonal Bioassays
    • Customized / Stand alone studies
    • Screening studies
    • Supplementary toxicity studies
    • Research and Development studies
    • Supply of quality serum, plasma from various laboratory animals
    • Ecotoxicity studies
    Bioavailability / Bioequivalence Studies
    Bioavailability / Bioequivalence Studies

      Infrastructure

    • Registration and Screening unit
    • Pharmacy
    • Clinical Ward
    • ICU
    • Bioanalytical laboratory
    • Quality Assurance unit

      Registration and Screening unit

    • Volunteer waiting lounge with recreation facilities
    • Prescreening
    • Registration
    • ECG
    • Blood and Urine sample collection
    • Clinical examination

      Pharmacy

    • Laminar Air flow for dispensing
    • Analytical balance for weighing of liquid investigational products
    • GPS enabled digital clocks for uniform time recording

      Clinical ward

    • Consent area with individual consent rooms equipped with audio-video recording through CCTV
    • Urine drugs of abuse & Alcohol breath
    • Change room with locker facility
    • Bathroom
    • Dosing & Vitals
    • Doctor & Monitors
    • Phlebotomy
    • Sample separation & storage
    • Dining
    • Entertainment

      ICU

    • Fowler Beds
    • Crash cart
    • Multipara monitor
    • Ambubag
    • Defibrillator
    • Suction apparatus
    • Emergency medicines
    • Oxygen cylinder

      Bioanalytical Laboratory

    • LC-MS/MS
    • Deep freezer (-80℃)
    • Refrigerated Centrifuge
    • Microbalance
    • Analytical balance
    • Nitrogen evaporator
    • Solid Phase Extraction unit
    • Micropipettes
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