Your Trusted Clinical Trials And
Compliance Partner
Clinical Trial Set-up and Strategic Advice
ADMFES facilitates the clinical trial startup process and offers additional flexibility in response to the clients’ outsourcing demands. ADMFES 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
Clinical Project Management
ADMFES 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
Clinical Trial Monitoring
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
Patient Safety in Clinical Trials
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.
ADMFES 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
Clinical Data Management
ADMFES 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
Clinical Biostatistics Services
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.
Quality assurance and Compliance
ADMFES ‘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.
ADMFES 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
Regulatory Affairs for Clinical Trials
ADMFES 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
