Our qualified project managers and experienced consultants provide regulatory information and quality assurance for successful project outcomes.
With every study, we assign a qualified project manager (PM) with a broad background in clinical research development whose skills best match the trial requirements. We understand that communication between the project manager and the client is a major factor for achieving successful project outcomes.
Improved, continuous communication and increased accountability ensure that the project stays on track, on time and within budget. Our structure improves accountability of deliverables and allows for improved peer-to-peer communication between Amarex's and the sponsor's PMs.
Our PMs must have appropriate training and experience in clinical research, and also receive additional training in these areas:
- Project plan creation
- Project management systems
- GCP and HIPAA guidelines and requirements
Our services include:
- Developing a project plan
- Creating a study operations manual
- Maintaining the trial master file
- Initiating preclinical and clinical trial setup
- Coordinating site selection, contracting and management
- Managing the Institutional Review Board (IRB) submission process and approvals
- Coordinating study vendors
- Managing site payments
- Managing all Amarex departments working on a trial
Our experienced consultants have worked on over 400 studies in more than 35 countries. Believing in a data-driven, collaborative approach, we provide accurate regulatory information and outstanding trial guidance. Amarex offers comprehensive operational and logistical tools, technically advanced services and forward-thinking solutions to products from initial concept to FDA approval.
Our services include:
- Clinical development plan
- Product development plan
- Statistical support
- Clinical study design
- Adaptive and enrichment clinical trials
- Rescue trials
- Medical writing and clinical research results evaluation
- Operational support for development projects
- Patient recruitment
- Non-clinical development (small molecules, biologics and medical devices)
- Data Safety Monitoring Board (DSMB) meetings
- Advisory committee meetings
- Regulatory strategy planning
- Due diligence assessments and compliance strategies
- Regulatory application submissions (U.S. and international)
Our quality assurance (QA) team ensures adherence to any applicable regulations from the FDA, the Health Products and Food Branch (HPFB) Inspectorate in Canada, the European Medicines Agency (EMA), the Taiwan Food and Drug Administration (TFDA) and other international agencies during each phase of the clinical trial process. Our team ensures that we comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and International Conference of Harmonisation (ICH) guidelines (E6).
Our QA team measures, assesses and reports quality data and seeks ways to continually improve quality performance and results. According to industry best practices, our corrective and preventive action (CAPA) process ensures that we investigate significant out-of-specification events, review deviations and discrepancies, report the findings and conclusions of the investigation, and implement and document corrective actions.
Our senior-level auditors conduct unbiased assessments of all aspects of a study, including auditing clinical sites and associated databases and vendors, validating software, and assuring the quality of individual reports, study files, tables and listings. Our QA team also offers training seminars to prepare investigator sites for regulatory inspections.
Our services include:
- Document audits
- FDA audit inspection preparedness trainings
- Clinical site, manufacturer site and laboratory audits (GCP, GMP, GLP and GAP)
- Review of clinical study protocols, preclinical study protocols, CRFs and study files
PharmacovigilanceOur highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials.
Regulatory AffairsOur regulatory department has vast experience working with regulatory authorities around the world.
Book a meeting or send us a message to talk to one of our experts.