Ayurveda

Ayurveda medicines are the oldest and most comprehensive scientific discipline known to mankind. The need for developing new therapeutics which are at least as effective as the currently available allopathic but having much higher levels of safety is being increasingly recognized. In the present scenario, the demand for herbal products is growing exponentially throughout the world and major pharmaceutical companies are currently conducting extensive research on plant materials for their potential medicinal value.

SMOconnect help herbal companies in conducting high quality clinical trials from Pre Clinical to all Phases of clinical trials by reducing the cost and time. We offer planning, designing, managing and analysis of trials in compliance of ICH GCP, Schedule Y and Ayush GCP guidelines.

Our extensive knowledge and expertise in clinical trials and wide network of hospitals and investigators can provide comprehensive solutions to all the needs of sponsor. Our team is all set to serve in all therapeutic indications. The strong SOPs help us to meet the timeline and generate quality data from the trial. The wide network of sites and expert team help us to provide cost effective solutions without compromising the quality.

Our services Includes

Preclinical studies

  • Toxicology and efficacy studies in animals

Clinical Trial Budgeting

Clinical Operations

  • Site selection & Site management
  • Trial Management
  • IP and Trial Material Management
  • Data Management
  • Monitoring
  • Clinical Study Report

Study Documentation

  • Documentation of clinical trial (TMF,PMF, SMF )
  • Quality System Management
  • Case Report Forms (CRFs)
  • SOP Development

Regulatory submissions

  • DCGI Submissions and Approval
  • EC submissions
  • EC Formation and Registration
  • Independent EC Services
  • CTRI Registration
  • ClinicalTrials.gov Registration

Medical writing

  • Preparation of Protocol
  • Investigator Brochure (IB) or Product Dossier
  • Case Report Forms (CRFs)
  • Informed consent form (ICF)
  • Subject Diaries
  • Study logs (delegation log, IP logs etc.)

Biostatistics service

  • Preparation of Study Design
  • Determination of sample size based on power analysis
  • Interim Analysis
  • Final Analysis & Report
  • Clinical Data Management
  • Both paper CRF and EDC
  • Designing CRF
  • Database development & maintenance
  • Quality Control & Quality Assurance
  • DCFs Generation/Resolving
  • External data management
  • Data entry and data processing

SMOconnect offers

  • Fast Regulatory Approvals through our regulatory experts
  • Right site selection with right patient pool ( Ayurveda or Allopathic sites)
  • Effective solutions adhering to the given timeframes
  • Quick recruitment and study completion
  • 100% Quality data generated through IMV and QA audits
  • Fully automated NABL Accredited central lab services
  • Advanced technologies like IVRS, IWRS, CTMS
  • Advanced Data Management solutions including EDC and paper CRF
  • Statistical Analysis using SAS software
  • Accurate Clinical Study Report by our Medical Writing Team.