Triumpharma Inc. is a pioneer in developing systems and solutions for advanced drug delivery. We strive to bridge the gap between life science and modern healthcare.

Triumpharma Inc. develops technologies that enhance the performance of many of today's commonly available pharmaceutical products and new chemical entities that give raise to challenging bioavailability problems.

Triumpharma has strong technical capabilities to take products from feasibility to pilot scale. Triumpharma conducts formulation optimization studies, pre-clinical trials on animals, human clinical studies including bioavailability/ bioequivalence trial complying with the international guidelines. The company's core advantages are its extremely low-cost base, experienced staff with multi national experience, holding PhDs from western universities, high-quality research, a large pool of patient’s and volunteers, and fast formulation development meeting the necessary regulatory requirements.

The data management unit’s  expertise within the pharmacology and pharmacokinetics fields as well as its knowledge of regulations requirements is the key to prepare clinical studies designs and protocols. The data management unit provides scientific support during the conduct of studies. Its role is to calculate & evaluate the study results and is involved preparation of final reports.

The data management unit provides scientific support for study teams in the area of pharmacology, pharmaceutics, pharmacokinetic & regulated guidelines for clinical trials conduct for  the enhancement of scientific foundation of Triumpharma.

The data management offer

Medical Writing

  • Preparation & review of clinical study protocol
  • Preparation & review of comprehensive final, validated data reports clinical study reports in compliance with regulatory guidelines (ICH), and consulting with sponsors on the interpretation and application of study results.

Pharmacokinetic Services

  • Study design (meeting international accepted guidelines recommendations)
  • BA/BE Assessments
  • PK Evaluation (Validated WinNonLin® software)
  • PK/PD Modeling (Validated WinNonLin® software)
  • Population kinetics

Statistical services

  • Statistical services
  • Sample size estimation
  • Statistical analysis of clinical data
  • Preparation of statistical analysis plans
  • Data reviews, interim analysis

Data Managements

  • Data entry
  • CRF design
  • Data base build & design according to Standard Operating procedures and protocol
  • Direct entry into sponsor database
  • Data validation
  • Automated query systems
  • Data Management consulting
  • Flexible data collection: Paper, EDC (using sponsors EDC), Fax, Voice/phone, PDA.

Collaborates closely with the sponsors to provide full-service and support, starting at study protocol inception and continuing through the final report.

 

This publication has been produced with the assistance of the European Union in cooperation with Jordan Enterprise Development Corporation. *

* The contents of this publication are the sole responsibility of Triumpharma and can in no way betaken to reflect the views of the European Union & Jordan Enterprise Development Corporation