Pleksus provides end-to-end support for Phase I–IV clinical trials and observational studies, covering the planning, start-up, conduct, and close-out phases. Our services include project management, regulatory submissions, ethics committee applications, patient recruitment strategies, monitoring activities, data management, biostatistics, medical writing, pharmacovigilance, quality assurance, and audit services. Our experienced team supports the efficient and timely execution of clinical research in compliance with national and international regulatory requirements, while upholding the principles of scientific quality, patient safety, and data integrity.
Clinical Trial Services
- Protocol Development
- E-CRF Development
- Ethics Committee and Health Authority Submissions
- Notification Submissions
- Amendment / Substantial Amendment Submissions
- Safety Report Submissions
- Progress Reports and Interim Safety Reviews
- Site Management
- Statistical Analysis
- Manuscript Writing
- Journal Submissions
- Investigational Product Management
- Customs Clearance
Clinical Development Safety
- Safety Data Submissions (SUSARs, etc.)
- Line Listing Submissions to Health Authority and Ethics Committee
- DSUR Submissions
- Fulfillment of Health Authority Requests