Services

Monitoring

JSR Pharma Solutions provides Bioavailability and Bioequivalence (BA/BE) studies and Clinical trials monitoring support. We provide complete assistance to Clients for all types of monitoring activities. All monitoring activities are conducted in accordance with ICH-GCP and applicable regulatory guideline requirements.

All Biostudies and trials are monitored in accordance with firm Standard Operating Procedures (SOPs) developed to meet GCP/GLP standards.

Types of monitoring services and scope:

Clinical:

  • Site Identification (SI)
  • Site Initiation visit (SIV)
  • Site monitoring Visit (SMV)
  • Site Closeout Visit (SCOV)
  • Retrospective Monitoring Visit (RMV)
  • Risk Based Monitoring (RBM)

Bioanalytical:

Method Development and Validation (MD/MV)- We will ensure following key areas during Anaytical Method Development / Validation.

  • MD is done with sufficient numbers of trials to come to accurate method.
  • Right interference and inference is drawn from the developed method.
  • Method is validated as per regulatory requirements.
  • Method is robust enough to avoid any issue in study sample analysis.

In Process Bioanalytical monitoring – We will ensure compliance in below mentioned key areas during sample analysis.

  • Accuracy during the analysis
  • Error-free stock weighing, CC/QC and Solution Preparation
  • Spiking, storage and accountability of CC/QC
  • Sample Processing as per Method SOP
  • Study Samples Accountability during receipt and storage
  • Calibration status of instruments before use

Retrospective Bioanalytical Monitoring (RTBA) - We will review following key areas for compliance once sample analysis is completed.

  • All the Raw data check, samples review.
  • Instrumentation review
  • All study data review including draft Bioanalytical Report review
  • Draft BA report verification against all the raw data

Pk & Stats Monitoring:

We offer Online and Retrospective Pk-Stats monitoring. Our experts can add value to the Final Report quality and accuracy. We also provide Biostatistics services through our associated partners