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Clinical Research

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Our Services

Clinical Research

  • Protocol development
    • Team has vast experience in developing protocols for single to multiple drugs, simple to complex drugs
    • Team has well knowledge to develop parallel, cross-over, reference replicate, full replicate, multiple dose, drug-drug interaction, steady state study protocols.
    • Team has experience in developing protocols for various formulations including tablets, capsules, solutions, suspensions, patches, modified releases, injections, nasal formulations, ODT, granules in apple sauce etc.
    • Team has experience in developing protocols.
    • Developing protocols involving healthy humans, young, elderly and patient populations.
    • Dedicated staff to deal with protocol design and development
    • Protocol development as per regulatory requirement
    • Sound scientific knowledge
    • Error free protocol preparation
    • Protocol review by investigators and QA
    • Turnaround time of just 3 days
    • Submission of protocol to IEC/IRB
    • CDSCO application
  • Clinical phase (BA/BE)
    • Pharmacokinetic and Pharmacodynamic studies
    • Mixed gender studies
    • Special population studies
    • Has 52 clinical beds
    • Two bedded fully equipped ICU
    • Large pool of volunteers
    • Trained and experienced investigators, pharmacist, paramedics, CRAs
    • Dedicated pharmacy chamber
    • Dedicated storage
    • Fully compliant to GCP
    • Biometric volunteer registration
    • Internal Quality control program
    • 24/7 operations
  • Bioanalytical phase
    • Analysis in biological matrices like whole blood, serum, plasma, urine and saliva
    • Analysis using LC-MS/MS
    • Team has vast experience in developing simple to complex methods
    • Dedicated storage and deep freezer custodian
    • 21 CFR part 11 compliance
    • Qualified systems
    • Trained and experienced staff
    • Hundreds of methods were developed by the team in their career
    • Method development
    • Method validation
    • Method transfer
    • Sample analysis
    • 24/7 operations
    • Fast turnaround time
  • Biostatistics and Data Management phase
    • Sample size calculations
    • Randomization
    • Preparation of plans
    • Pharmacokinetic analysis
    • Statistical analysis
    • Data filing, scanning and management
    • SAS programs
    • Preparation of reports
  • Clinical trials
    • We support our clients in conducting clinical trials
    • Tied up with clinical investigators at various hospitals
    • All kinds of segments
    • Different patient pool
    • India wide tie up with investigators
    • Phase I to IV services
    • Site identification, initiation and monitoring
    • Site training and audit
    • Regulatory support
    • Master Data management
  • Quality Control and Quality Assurance
    • Quality control to monitor online activities
    • Quality Assurance to ensure quality and compliance
    • Study based audits
    • Risk based audits
    • Internal system audits
    • Vendor audits
    • Document control, distribution and archive
  • Regulatory
    • We support our clients in meeting the regulatory requirements
    • We ensure to adopt new guidelines from time to time
    • Regulatory submission
    • e-CTD review
    • Query resolution
    • Bio-waiver
  • Report or e-CTD
    • Clinical study report, Bioanalytical report and statistical report
    • Preparation of e-CTD in line with regulatory

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