GCP SERVICES

Effective project management is the bedrock of any trial; Our project management team will provide the necessary leadership to plan and execute the cross-functional activity of the projects. It’s imperative that your project is managed by people moving in the same direction, towards clearly defined and shared goals. We use best-in-class technology to support our delivery by enabling the project management team to focus on project milestones and performance while proactively managing quality, risks and issues. Having this information centralized across the project keeps everyone informed and on the same track. Every clinical trial we work on teaches us something new, and that’s how we improve. We refine our processes as we find new ways to be more effective and efficient in everything what we do, in order to provide you with a seamless project management service.

Pharmazone has highly experienced Project Managers who are responsive, proactive, and will ensure that the right resources are used with established processes and procedures to maximize efficiency throughout your study. They provide leadership and oversight to our study teams and serve as a single point of contact for our sponsors. Our Project Managers 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 Organizations (CRO) Audits

From selecting best CRO to upgrade your own system as CRO and from feasibility of trial to investigation of unanticipated results, Pharmazone has lot to offer you in Auditing section. Below are the few glimpse on various types of audits.

System & Facility Audit

System and Facility Audit is to evaluate the site/CRO capabilities to conduct BA/BE study and the compliance status with respect to current Good Clinical Practice and Good Laboratory Practice and applicable regulatory and ethical guidelines.

Feasibility Audit

Feasibility audit includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a proposed location. The outcome will allow the sponsor and qualified PI to make an informed decision regarding the feasibility of the study at his/her site.

GAP Audit

GAP provides an objective assessment of organizational efficiency, compliance with applicable regulations, and adequacy of quality systems. A successful gap analysis identifies necessary changes in process, organization, and resources, and maps out a systematic approach for implementing solutions that effectively minimize risks to the organization.

For-Cause Investigation

Who likes unanticipated results. In Clinical Research there are multiple chances of small error which becomes deciding factor for success of any Trials. It becomes very essential to identify root cause of error by investigation for its corrective as well as preventive action. Pharmazone Auditors are having niche experience in such kind of audits and will analyze project with 360° investigation approach with utilizing all expertise from formulation, biostatistics, clinical and bioanalytical as needed, to find out the any possible reason.

  • This helps in finding out any issue/human error in the conduct of a study.
  • Correlating sequencing of event in chronological order to identify the error or cause of error.
  • To search any assignable cause that may have caused any anomaly by reviewing all clinical, bioanalytical, PK-state data together to see the possible correlation.
  • To see the impact of protocol design on such outcome.
  • To design the best possible way forward.

Site Qualification Audit/Re-Qualification

Site Qualification Audit/Re-Qualification is also referred to as “pre-study qualification visits” or “site visits,” to select qualified Investigators and to determine the investigative site’s ability to conduct the clinical investigation prior to commencement of the study. In order to be selected, Investigators must be qualified by training, education, and experience and have adequate resources, staffing, and facilities to conduct the proposed investigation. In some instances, sponsors elect to allow some combination of Investigator meetings and/or an initiation visit to suffice as a pre-study qualification visit.

Regulatory Compliance Audit

Regulatory Compliance Audit is a compliance audit is a comprehensive review of an organization’s adherence to specific regulatory guidelines & specifications mentioned and to evaluate the strength and thoroughness of compliance preparedness.

GCP/GLP Audit

GCP/GLP Audit is conducted retrospectively to evaluate site/study and to check compliance to trial protocols, Standard Operating Procedures, Good Clinical Practice, Good Laboratory practices and the applicable regulatory requirements and risk Assessment. A systematic process of organizing information to support a risk decision to be made within a. risk management process.

Hospital site

Decision to select any investigator is tough to made just only reviewing the experience of him will not land any expected results, auditing site is. Pharmazone team is well versed and they evaluate the site’s capabilities to conduct Clinical Trial and the compliance status with respect to current Good Clinical Practice and Good Laboratory Practice and applicable regulatory and ethical guidelines.

Phase I facility

Phase I unit should be built and developed in such manner that it suffices all requirements of regulatory as well as safety and Pharmazone team has niche experience to assess and audit Phase I facility with respect to specific molecular requirement as well as sponsor specific & regulatory requirements.

Archival facility

Archival of documents as per regulatory requirements are imperative whether it is electronic copies or hard copies. Audit of Archival facility include thorough review of archival system including SOP, storage facility, capacity, archival/retrieval/archival process, techniques to preserve documents for long time, fire proof requirements as per local regulatory etc.

Central Pharmacy

In Clinical Trials, logistics surrounding pharmacy distribution can be challenging, Central Pharmacy serves a purpose however before assigning any central pharmacy to your project, essential qualification audit is essential to analyze the system, SOP, applicable certification, control over storage requirements, accountability handling etc.

Supply chain Warehouse

Creating efficient and effective warehousing and distribution systems is an extremely important that is vital to supply chain management. Our Auditors ensures that warehouse are design and construct according to requirements, environment is controlled with temperature and humidity, management and organization of warehousing and inventories etc.

Pre-clinical facility

In early research pre-clinical trials plays vital role for future of expected molecules. Audit of Pre-Clinical Trial includes extensive review of SOP, Facility, storage facility, departments of DMPK, safety Pharmacology, toxicology, applicable regulatory guideline to be followed eg. GLP, OECD etc.

Central Pathology Lab

Audit of Central pathology laboratory is to evaluate the laboratory’s capabilities to handle expected number of samples, its analysis, applicable instruments qualification and the compliance status with respect to current Good Laboratory Practice and applicable regulatory guidelines.

Computer system validation

Pharmazone provides a complete solution to Computer System Compliance. With our CSV Auditing service we audit in all stages of the life cycle of a computerized system whether it’s being used in clinical development, drug safety, a laboratory or manufacturing facility.  Audit can be comprehensive or focus on a particular functional area, business operation, or computer system, as per your requirements. We verify compliance with 21 CFR Part 11 and other FDA regulations and guidelines, Good Automated Manufacturing Practice (GAMP), ICH guidance, and Annex 11, if appropriate. We also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, record retention, and problem reporting.

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.
  • Furthermore, Pharmazone has very specialized Recruitment and Training System, where we 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

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  • 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.

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