PharmXL facilitates the clinical trial startup process and offers additional flexibility in response to the clients’ outsourcing demands. PharmXL has highly experienced staff to initiate the clinical trials by providing -

Optimization/strategic feasibility

Country/site selection

Strategic site partnerships

Investigator qualification

Site activation (local regulatory submissions, site contracting and clinical startup)

Patient recruitment

PharmXL designates a Project Manager (PM) selected based on their background and skills aligning with the project needs. Collaborating with our PMs, we redefine the meaning of "partnership" by ensuring clear communication of your expectations from study start-up to closeout. The project manager oversees both technical and administrative aspects of the study, adhering to the client's defined parameters.

A project Manager:

Ensure adherence to Good Clinical Practices

Deliver on our promise to meet milestones and use real-time metrics to demonstrate our success

Provide a single point of contact for our clients.

Put risk and contingency plans in place which anticipates and prevents problems

Manage budgets to minimize change orders

Keep you as informed as you need to be through frequent verbal communications and teleconferences, along with monthly customized reports

Escalate important issues quickly and offer solutions

Take ownership of your project and all its deliverables

Our Clinical Trial experts play a pivotal role in overseeing all trial activities, coordinating through study team meetings, and managing tasks from study start-up to close-outs. They utilize our proprietary Clinical Trials Management System to maintain up-to-date information on study status, patient enrollment, site details, and track deadlines and milestones for regulatory documents and submissions.

The Clinical Research Associates manages site visit objectives, including:

Study & site startup activities

IRB/EC meeting activity

Ensuring compliance to protocol, SOPs, contracts & budgets

Study subject Screening and enrollment

SOPs, Regulatory documents (electronic and hard-copy)

Monitoring visit Reports, calendars and schedules

Safety reporting and regulatory submissions

Ensuring signed informed consent forms

Source Data Verification (SDV), based on the protocol and study plans

Reviewing all eCRF/CRFs with site staff for trends and SAEs

Performing drug accountability

Reviewing investigator study files for completeness

Encouraging and supporting sites

Effectively managing serious adverse events is a pivotal responsibility in any successful clinical trial. Our team of highly experienced clinical research physicians offers medical expertise to assess safety issues that may arise during the study, ensuring a comprehensive approach to risk management throughout the trial period.

PharmXL provide a comprehensive and flexible suite of drug safety services during the clinical trial:

Coordination of data safety monitoring committees

24/7- Serious Adverse Event (SAE) assessment and reporting

Medical review of adverse events and all clinical trial related

Development Safety Update Report (DSUR) writing

Investigator and Ethic Committee safety notifications

PharmXL maintains data integrity through rigorous adherence to well-established data management operating procedures. Collaborating closely with our partners, we deliver precise data to meet project deadlines effectively while strictly adhering to Good Clinical Data Management Practices (GCDMP).

Our Clinical Data Management commitment includes:

Electronic Data Capture (EDC) System Training for Sites & Monitors

System Validation

eCRF and paper design

Data Management Documentation (DMP, DVP, DMR, etc.)

Database set-up, Data Entry, Medical Coding, Data Validation and Cleaning

Import, Integration, and Cleaning of electronic data (Lab, ECG, PK, Diary, etc)

Reconciliation of SAE, lab, ECG, imaging data, etc.

24/7 EDC Helpdesk

Secure web portal for real-time access to study progress reports, query reports, subject data listings and summary tables, etc.

Ongoing support for users of data management systems and tools, including user training and helpdesk operation.

Data migration

Database lock and archival

Our biostatistics team offers comprehensive support across all stages of the process, delivering a full range of statistical services for clinical development planning, execution, and analysis throughout various phases of clinical trials.

Our Biostatistics Services include:

Full service or independent biostatistical and programming support

Protocol and statistical analysis plan development

Study Design & Endpoint Development

Sample Size/ Power Calculations

Randomization Schedule Preparation

Statistical Analysis Plan Development

Meta Analysis/Post Hoc Analysis

Pharmacokinetic (PK) Analysis

Interim analyses and co-ordination of Data Safety Monitoring Committee

Preparation of integrated summaries of safety and efficacy for regulatory submissions

Preparation and validation of tables, listings and graphs.

PharmXL's Quality Assurance (QA) takes responsibility for conducting periodic audits of various clinical trial processes to establish a robust quality management system (QMS). Collaborating closely with clients, the QA team discusses service requirements and scope.

PharmXL provides following QA services to meet the regulatory authority compliance for clinical trials include

Audits for Vendor, investigator site

System and Study audits (e.g., pharmacovigilance and data base)

Clinical Report and Trial Master file Audit

Protocol Development and Investigator Brochure Audit

Clinical Laboratory Audit

Pre-inspection audits

Writing, reviewing and updating SOPs

Developing, reviewing and updating QMS

PharmXL provides End to End regulatory support for clinical trials. We prepare and submit clinical trial applications to regulatory authorities (RA) and perform follow up as per RA requirement.

Our regulatory support includes:

Liaoning of investigators with the Institutional Review Board or Ethics Committee

Submission of DSUR, SAEs and other reports as per RA requirements

Submission of clinical study reports

Study transparency/disclosure

Supports import, supply, and management of investigational products.

Study drug import and management

Study drug import and management

Permission for Import/export of investigational product and biological samples

Management of Investigational product:

Local label design

Storage & Distribution

Return & destruction

Facilitation and management of service vendors