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.
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.
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 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 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 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.
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.
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 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 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.
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 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 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.
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.
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.
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.
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.
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.
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.
We See What Others Don’t.
Pharmazone experts visit sites well before trial commencement and ensure following items during SIV.
Pharmazone experts visit sites during the trial commencement as per monitoring visit scope and requirements and ensure following items during visit.
Our Monitors will ensure compliance in following key areas during IPBA visit
Our Monitors will thoroughly review following key areas for compliance during RTBA visit, once sample analysis is over.
Our Monitors will ensure following key areas
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.