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肿瘤领域

医学影像诊断在评估新型肿瘤药品的有效性和安全性方面发挥着重要的作用。医学影像诊断与肿瘤学领域临床试验的成功整合需要专业的方案设计、扎实的终端成像理论以及对法规要求的深入洞悉。

作为申办方,您可能既希望您的试验能运用当下肿瘤影像的最新科技,又要求项目能及时完成并在可控的预算之内。 针对这一需求,BioClinica为您提供了这一整合行业领先学术科技及高效项目管理为一体的解决方案。

  • 拥有精通肿瘤成像模式及成像终端的资深医学与学科专家。
  • 拥有全职的肿瘤学家和放射学家,以及由全球互动的关键意见领袖组成的专家团队。
  • 注重时限,进度指标以及成本控制的统一的项目管理团队
  • 在肿瘤药物审批方面,拥有无可比拟的与监管部门合作的经验

BioClinica很荣幸地成功协助客户完成了31项FDA审批的肿瘤药物,该数量在全球影像核心实验室中排名第一。

链接至FDA批准药物目录

Drug Name Indication
Adcetris Anaplastic Large Cell Lymphoma
Alimta Mesothelioma
Avastin Renal Cell Carcinoma
Bevacizumab Non-Small Cell Lung Cancer, Breast Cancer, Glioblastoma
Bexxar Non-Hodgkin's Lymphoma
Crizotonib Advanced malignancies
Denosumab Prostate Cancer , Breast Cancer, Multiple Myeloma
Doxil Multiple Myeloma
Eloxatin Colorectal Cancer
Erbitux Colorectal Cancer
Gadovist Breast Cancer
Ixempra Breast Cancer
Nexavar Renal Cell Carcinoma
Perjeta Metastatic Breast Cancer
Pralatrexate Lymphoma
Provenge Prostate Cancer
Regorafenib GI Stromal Tumor
Rituxan Non-Hodgkin's Lymphoma
Sutent GI Stromal Tumor and Renal Cell Carcinoma
Tarceva Non-Small Cell Cancer
Torisel Renal Cell Carcinoma
Trastuzumab Breast Cancer
Treanda Non Hodgkin Lymphoma
Tykerb Breast Cancer
Vectibix Colorectal Cancer
Velcade Multiple Myeloma
Zactima Thyroid Cancer
Zevalin Non-Hodgkin's Lymphoma
Zydelig Chronic Lymphocytic Leukemia

拥有参制定法规流程的丰富经验

我们的专家熟知FDA、EMA、CFDA、PMDA和其它国际监管机构制定的指南及规定,在临床试验影像终点的新规范制定中起到了积极的领导作用。在章程制定以及方案撰写方面的丰富经验意味着我们能够有效地实施试验并对政府部门的审查胸有成竹。BioClinica保证所有影像数据的完整归档,还并且所有流程均完全符合《美国联邦法规》(CFR)21章第11条的规定。

心脏肿瘤学
BioClinica在设计和实施心脏安全研究 方面(即ICH-E14中明确要求的全面QT研究及血压监测等)拥有丰富的专业知识,有助于在临床早期阶段对肿瘤药品进行评估。

试验经验

BioClinica成功参与了800多项肿瘤领域的临床试验,其中涵盖了广泛的适应症及临床研究的各阶段。 在将肿瘤影像技术运用于评价临床试验中受试者的合格性(受试者的入排选标准)、试验的有效性(主要和次要终端终点事件)以及药物的安全性(评估安全相关指标)等方面,我们拥有丰富的经验。

BioClinica参与过肿瘤领域多种适应症的临床研究

指征表

Brain Cancer
Breast Cancer
Carcinoid Ascites
Chronic Myeloid Leukemia
Colorectal Cancer
Gastric Cancer
GI Stromal Tumor
Head and Neck Cancer
Liver Cancer
Lung Cancer
Lymphoma
Melanoma
Mesothelioma
Multiple Myeloma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Renal Cell Carcinoma
Sarcomas
Transition Cell Carcinoma of Urothelium
Thyroid Cancer

创新

BioClinica的肿瘤学团队在分子成像、肿瘤生物标志物和肿瘤反应标准方面走在了全球的最前沿。

肿瘤学的肿瘤反应标准

  • Cheson
  • Choi
  • EBMT
  • EORTC
  • Hallek
  • IHP
  • Macdonald
  • PCWG2
  • PERCIST
  • RANO
  • RECIST 1.0/1.1
  • 容量评估
  • 世界卫生组织(WHO)方法学
  • Wolchock免疫相关反应标准
  • Response Criteria

分子成像终端

  • 64Cu diacetyl-bis (N4-methylthiosemicarbazone) (ATSM)
  • 18F-fluorodeoxyglucose (FDG)
  • 18F-Fluoride
  • 3'-deoxy-3'-18F-fluorothymidine (FLT)
  • 18F-fluoromisonidazole (FMISO)
  • 111In-octreotide
  • 123I-metaiodobenzylguanidine (mIBG)
  • 锝-99m

为了最大限度地发挥BioClinica在临床、技术和运营上能力,我们与很多重要的行业协会保持着良好的关系:

  • 指标冠军组织(MCC)
  • 美国药物研究和制造商组织(PhRMA)
  • 药品信息协会(DIA)
  • 北美放射学会(RSNA)
  • 影像临床试验统一方案(UPICT)
  • 定性影像生物标志物联盟(QIBA)

LEARN MORE OR SPEAK WITH OUR EXPERTS

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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