Early & Late Phase Clinical Trials

Triumpharma is specialized in early phase to late stage clinical trials through different phases of clinical development ranging from Phase I to Phase IV (for small and large molecules),  including First-in-Human through Proof of Concept (POC), Rare diseases/Orphan drugs, Narcotic/controlled drug substance , Biosimilars and Biotech drugs (both Mab & protein derived

Triumpharma Experience in clinical trials (Phase I)

  • Triumpharma Clinical Evaluation Centre is the leading CRO in the conduct of clinical trials in the region with the right quality and experience.
  • Conducted several single center and global multi-centric, (Phase I-III), on healthy subjects and patient’s based clinical trials. The patients based clinical trials are covering various patient population and wide therapeutic areas.
  • Completed several Proof of concept (POC) indications (such as Phase I/ Mixed dyslipideamia, Phase Ib/ Warm Autoimmune Hemolytic Anemia and Phase II/ Intermittent claudication). In addition to our experience in early phase studies such as Asthma, NASH, Diabetic nephropathy, Parkinson, AF (atrial fibrillation), Diabetes, and others. Triumpharma Clinical Evaluation Centre was the Highest Recruiting Site for some of these clinical trials.  
  • In addition to our clinical owned sites, we have access to more than 6000 patients and over 5000 HVs.
  • Worked with more than 5 local hospital sites and with global specialist courier for clinical trials, transport of clinical and medical research and logistics management (example: world courier, PDP, etc).
  • Our team are highly experienced in using many EDC systems such as: Medidata Rave, Oracle, IMPACT, and Almac Sciences. In addition to our experience using Interactive Voice and Web Response Systems (iXRS) for patient randomization, dosing and clinical supply inventory management; iDiary phone-based patient diary data

Phase 1 studies conducted by Triumpharma

  • First-in-Man Studies (POCs)
  • Tolerability and pharmacokinetics of escalating single doses
  • Tolerability and pharmacokinetics of repeated doses.
  • Pharmacodynamics of single doses
  • Pharmacodynamics of repeated doses
  • Relative bioavailability.
  • Absolute bioavailability.
  • Food effect studies
  • Drug-Drug Interaction (DDI)