PharmXL provides a full and comprehensive clinical trials service from Phase I to IV. We're also pleased to undertake studies with specialist requirements or with niche products. Our services span:
PharmXL further provide supports on import and supply and management of clinical trial investigational products.
PharmXL consolidates the vast majority of our startup activities into a global business unit. Our employs state-of-the-art technologies to help facilitate the startup process drive industry-leading cycle times and offer additional flexibility in response to our clients’ outsourcing demands. This area includes service areas aligned in a uniquely holistic manner, including trial optimization/strategic feasibility, country/site selection, strategic site partnerships, investigator qualification, site activation (local regulatory submissions, site contracting and clinical startup) and patient recruitment. Site identification and activation is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships.
PharmXL has highly experienced staff to initiate your clinical trials by providing;
• Regulatory strategies
• Facilitation with FDA / EMEA / Japan regulatory agencies
• Development planning / protocol design / biostatistics
• Guidance on formulation / labeling / packaging
• Key Opinion Leaders (KOLs)
• Clinical site feasibility and selection
• Recruitment and enrollment
• IND preparation / submission / meeting
The project manager is a critical part of a study’s success. With every project, PharmXL appoints a Project Manager (PM) whose background and skills best match the project requirements. When you work with our PMs, we believe that the word "partnership" will take on a new meaning as we ensure that your expectations are clear upon study start-up and are met all the way to study closeout. The project manager is responsible for the technical and administrative aspects of the study as defined by the client.
A project Manager:
Our Clinical Trial experts are the backbone of every trial and manages all activities coordinated thorough study team meetings and communications, including study start-up activities, maintenance to study close-outs by utilizing our proprietary CTMS to report up-to-date study status, patient enrollment, site information and deadline and milestone tracking for regulatory documents and submissions.
CRAs will manage site visit objectives, including:
• Full SOPs (Standard Operating Procedures)
• Study & site startup activities
• Documents and Submissions
• IRB/EC meeting activity
• Contracts & budgets
• Screening and enrollment
• Study subject activity throughout the trial
• Regulatory documents (electronic and hard-copy)
• Monitoring visit Reports, calendars and schedules
• Safety Reporting
• Source Data Verification (SDV), based on the protocol and study plans
• Reviewing all eCRF/CRFs and discuss trends with site staff
• Evaluating eCRF/CRFs for serious adverse events
• Performing drug accountability
• Reviewing investigator study files for completeness
• Ensuring protocol compliance
• Encouraging and supporting sites
Management of serious adverse event is one of the crucial tasks for any successful clinical trial. Our highly experienced clinical research physicians provide medical expertise to evaluate the safety issues arises during clinical trial study and provide a safeguard to manage risk throughout study period.
PharmXL provide a comprehensive and flexible suite of drug safety services during the clinical trial:
Investigator and Ethic Committee safety notifications
Data integrity always plays a major role to a any successful clinical study. PharmXL ensures this integrity by strict adherence with well established data management operating procedures. Working together with our partners we provide an immaculate form of data to meet our project deadlines. Our data management experts comply with Good Clinical Data Management Practices (GCDMP). Our Clinical Data Management commitment includes:
Biostatisticians always play a crucial role in planning and preparation of any clinical trial study. Our biostatistics team supports every step of the process and provides full range of statistical services for clinical development planning, execution, and analysis throughout clinical trial phases.
Our Biostatistics Services include:
PharmXL Quality assurance (QA) responsible for the conduct of periodic audit for various clinical trial processes to establish a quality management system (QMS). Our QA team audit the our internal, project site as well as vendor site audit, it include clinical report, protocol development, investigator brochure and clinical laboratory audits.Our QA team meets and discusses the client’s needs and scope of the services. Our auditor prepared a audit plan which is reviewed and approved by our client.Further, within 15 days of audit, our auditor shared a draft audit report to our client.
PharmXL provides following QA services to meet the regulatory authority compliance for clinical trials include