Scientia Clinical Research(SCR)是一家通過美國 FDA 審核的臨床研究機構,專門承接製藥與生技公司早期階段臨床試驗。
試驗類型包括:首次人體試驗(First-time-in-human)、首次病人試驗(First-time-in-patient)、單劑量/多劑量遞增試驗(SAD/MAD)、概念驗證試驗(Proof of Concept)、藥物動力學/藥效學(PK/PD)研究、食物效應試驗、藥物交互作用研究、QTc 延長風險評估(thorough QTc)、民族藥理學研究、劑型開發研究(我們現場設有 Grade C 製劑生產區)、各類特殊試驗(可整合多項藥效學指標,如流式細胞儀與細胞激素分析)。
擁有涵蓋小分子與生物製劑的豐富經驗,應用於多種治療領域。
Scientia Clinical Research (SCR) is FDA audited and specialises in early phase clinical trials for pharmaceutical and biotech companies.
Our studies include first-time-in-human, first-time-in-patient, single and multiple ascending dose studies (SAD/MAD), proof of concept studies, PK/PD studies, food effect studies, drug interaction studies, thorough QTc studies, ethno pharmacology studies, formulation studies (Grade C manufacturing suite onsite) and specialty studies incorporating a range of pharmacodynamic markers such as flow cytometry and cytokine analysis.
We have experience with both small molecules and biologics across a wide range of therapeutic areas.