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GCP SERVICES

We offer many GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive, hands-on GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

  • Knowledge: Various regulatory requirements.
  • Experience: Seasoned GCP auditors.
  • Strong Project Management: Each assignment has a project manager with responsibility for project success, acting as a SPOC.
  • Value: Our auditor/monitors are competent and efficient, producing results as quickly as possible.
  • Speed: Time is critical when study execution/quality issues arise. We mobilize quickly to assist our GCP clients across globe.
  • Solution oriented approach: We can provide a number of cost effective solutions such as audit partnerships to support clients in meeting their regulatory requirements

 

PROJECT MANAGEMENT

Our Project Managers provide leadership and oversight to our study teams and serve as a single point of contact for our sponsors. They have extensive experience in clinical research, leveraging their therapeutic focus and experience to coordinate complex clinical trials. We believe that timelines and critical milestones are met through focus, priority, and relevant experience.

AUDITS

  • The success of any clinical trial/BABE projects depends on assuring that the data collected are of good quality. A well organize system audit will point out potential problem areas early, so that the solutions can be found before it is too late. This can be ensured by various type of audits.
  • Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a site audit program and the approaches taken towards designing and managing audits are constantly evolving. Pharmazone Auditors has extensive experiences in their respective subject matter to accomplish objective of audit.

Clinical Research Organisation Adults

  • System & Facility Audit
  • GAP Audit
  • For-cause Investigation
  • Site Qualification Audit
  • Regulatory Compliance Audit

Pre-clinical facility

Hospital site and / or Phase i facility

Computer system validation

Central Pharmacy and / or Supply chain Warehouse

Center Pathology Lab

Archival Facility

Monitoring-Clinical Phase

audit

Pharmazone leads the industry in providing advanced solutions for various types of Monitoring services in GCP-GLP. We offer high quality and deliverable based monitoring services to manage a trial on time and on budget.

  • With offices in many countries, we’re in the best position for clinical monitoring. Our teams have local knowledge so they understand the nuances involved in each market; from regulatory differences to cultural sensitivities.
  • We initiate projects quickly, with teams primed and ready to push the process through.
  • In Addition, pharmazone has several medical monitors who are highly experienced in industry for subject related matter eg. Cardiology, Oncology, Gastroenterology, Psychology etc.
  • Pharmazone monitors ensure the integrity of the study, adherence to protocol, quality of measurements, safety of Subjects, and the collection of valid data, and applicable regulatory requirements.
  • Also, very specialized Recruitment and Training System select talented professionals and cultivate their skills through an extensive training program on all facets of clinical research and trial oversight.

Types of Monitoring Services and Scope

We See What Others Don’t.

  • With monitoring experience in many countries, we’re in the best position for clinical monitoring. Our teams have local knowledge so they understand the nuances involved in each market; from regulatory differences to cultural sensitivities.
  • We initiate projects quickly, with teams primed and ready to push the process through.
  • In Addition, pharmazone has several medical monitors who are key opinion leaders eg. Cardiology, Oncology, Gastroenterology, Psychology etc.

Pharmazone experts visit sites well before trial commencement and ensure following items during SIV.

  • Advance error Evaluation and resolution in Protocol/ICF/CRF & other documents.
  • Gives a chance to site to be ready
  • Practical issue resolution well before study
  • Evaluation of capabilities of Site staff & Vendors
  • Resolution of Safety issues
  • Advance query resolution in terms of regulatory requirements

Pharmazone experts visit sites during the trial commencement as per monitoring visit scope and requirements and ensure following items during visit.

  • Original and Transparent view of your trial at your desk
  • On time updates of your projects including subject enrollment, dosing, unexpected AE/SAE or withdrawal etc. our Project Manager keeps you updated
  • Evaluation of right recruitment process
  • Eliminating possibilities of Informed Consent Process related concerns and recruiting unfit volunteers
  • Thorough evaluation of Cross-Participation process
  • Complete accountability of Investigational Product
  • Assurance of right IMP dosing with right randomization code
  • With presence of Pharmazone monitors, it allows to avoid any under reporting of AE/SAE/Withdrawal
  • Continuous monitoring can avoid sample swap or mixing of samples during processing
  • Each and every aspect of the study to ensure 100% compliance to regulatory, protocol and in-house SOPs.

  • This is very essential to ensure that site has taken appropriate CAPA on any or above monitoring Visit.
  • AE and SAE-Serious Adverse Event details check Reporting
  • IMP accountability after completion of study.
  • Samples storage requirements and accountability.
  • Draft report review along with source data review to ensure appropriate transcriptions.

  • This is generally conducted after completion of Clinical Phase and/or when the draft report is ready.
  • This ensure error free reporting
  • Complete source data review allows reporting and resolution of any error before submitting as a report

Risk based monitoring approach

audit
  • With advent of Risk Based Monitoring Approach, it has become quite imperative to conduct the monitoring of Clinical Research with pre-assessment of risk involved. Data-driven oversight is tailored to specific risk area of a study. Monitoring ways and approaches are continuously updated via robust data analysis.
  • Due to regulatory changes in clinical trials, such as the introduction of the addendum to the ICH GCP E6(R2), new FDA guidelines for industry on risk-based monitoring (RBM), and the European Medicines Agency’s (EMA) reflection paper on risk-based quality management, the urgency of the RBM process implementation has increased in most biopharma establishments.
  • Pharmazone has well defined SOPs for conduct of Risk Based Monitoring (RMB) of Clinical and Bioanalytical Phase.

Bioanalytical Phase

In process Bioanalytical Monitoring

Our Monitors will ensure compliance in following key areas during IPBA visit

  • Accuracy in initial experiments before start of analysis
  • The error- free stock weighing, CC/QC Preparation, Spiking, storage and accountability of CC/QC.
  • Accurate solution preparation.
  • Total accountability of Study sample receipt and storage.
  • Processing of study samples according to Method SOP
  • Calibration status before use of instruments.
Retrospective Bioanalytical Monitoring

Our Monitors will thoroughly review following key areas for compliance during RTBA visit, once sample analysis is over.

  • All the Raw data check, samples review
  • Instrumentation review,
  • All study data including draft Bioanalytical Report review.
  • Draft BA report verification against all the raw data.
Pre-study Method Development and Validation (MD/MV)

Our Monitors will ensure following key areas

  • To ensure that Method Development is done with sufficient numbers of trials to come to accurate method.
  • To ensure that right interference and inference is drawn from the developed method.
  • Ensures that method is validated as per regulatory requirements without missing any critical experiment.
  • To have the confidence that developed method is robust enough to avoid any issue in study sample analysis.

PK-Stats Monitoring

Pharmacokinetics and Statistical monitoring is new concept in clinical research. We offer online and retrospective PK-Stat monitoring. Our experts can add value to the reporting quality and accuracy.