医疗器械临床试验的设计与管理(策略&挑战)(精)

Brand: 中国科学技术    Sold By: EM China
医疗器械临床试验的设计与管理(策略&挑战)(精)
医疗器械临床试验的设计与管理(策略&挑战)(精)
医疗器械临床试验的设计与管理(策略&挑战)(精)
医疗器械临床试验的设计与管理(策略&挑战)(精)

医疗器械临床试验的设计与管理(策略&挑战)(精)

Brand: 中国科学技术    Sold By: EM China
$39.72 In Stock
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医疗器械临床试验的设计与管理(策略&挑战)(精)

医疗器械临床试验的设计与管理(策略&挑战)(精)

$39.72

  内容简介本书引进自世界知名的WILEY出版社,由Proteus生物医药公司高...
Product Details

 
内容简介
本书引进自世界知名的WILEY出版社,由Proteus生物医药公司高级临床运营经理Salah M.Abdel-Aleem博士领衔编写,是一部系统介绍医疗器械临床方案的设计、研究的执行和试验管理的实用指导书。本书内容全面丰富,着重介绍了临床研究方案中多中心临床试验研究中心和临床试验终点的选择、研究合同及知情同意,临床试验管理中缓慢入组、缺失数据分析、方案偏离和不良事件的识别与报告,临床试验中选择历史对照组代替阳性对照组,识别和避免临床试验中的欺诈和不当行为;分析了医疗器械法规的异同,以及欧盟CE标准和其他 临床标准;讨论了FDA PMA案例中非传统终点被用作研究的主要终点的临床研究。书中所述的专业知识兼具深度和广度,不仅适用于医疗器械临床试验研究领域的工作人员,其设计和管理同样适用于药物临床试验研究,可作为临床科学家、临床管理人员、生物统计学家、数据管理人员和临床协调员的参考用书。
目  录
第1章 临床研究设计面临的挑战
一、临床SOP的制订
二、受试者、研究者和研究中心的选择
三、临床研究人组受试者的定义
四、研究用医疗器械系统的定义
五、研究合同的有关挑战
六、文献述评
七、研究方案设计、统计分析计划(SAP)和选择临床试验终点所面临的挑战
八、盲法或设盲
九、主要和次要终点
十、临床试验终点的选择
十一、FDA和CE认证研究中主要终点之间的差异
十二、SAP和临床试验终点
十三、用于临床试验的SAP组成部分
商品详情

博库网旗舰店

基本信息
  商品名称:医疗器械临床试验的设计与管理(策略&挑战)(精)
  作者:(美)萨拉赫·M.阿卜杜勒-阿莱姆|责编:方金林|译者:赵大海   定 价:68   开本:16开
  出版社:中国科学技术   ISBN号:9787504690142   页数:221
  出版时间:2021-07-01   版次:1   商品类型:图书
  印刷时间:2021-07-01   印次:1   

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

 
内容简介
本书引进自世界知名的WILEY出版社,由Proteus生物医药公司高级临床运营经理Salah M.Abdel-Aleem博士领衔编写,是一部系统介绍医疗器械临床方案的设计、研究的执行和试验管理的实用指导书。本书内容全面丰富,着重介绍了临床研究方案中多中心临床试验研究中心和临床试验终点的选择、研究合同及知情同意,临床试验管理中缓慢入组、缺失数据分析、方案偏离和不良事件的识别与报告,临床试验中选择历史对照组代替阳性对照组,识别和避免临床试验中的欺诈和不当行为;分析了医疗器械法规的异同,以及欧盟CE标准和其他 临床标准;讨论了FDA PMA案例中非传统终点被用作研究的主要终点的临床研究。书中所述的专业知识兼具深度和广度,不仅适用于医疗器械临床试验研究领域的工作人员,其设计和管理同样适用于药物临床试验研究,可作为临床科学家、临床管理人员、生物统计学家、数据管理人员和临床协调员的参考用书。
目  录
第1章 临床研究设计面临的挑战
一、临床SOP的制订
二、受试者、研究者和研究中心的选择
三、临床研究人组受试者的定义
四、研究用医疗器械系统的定义
五、研究合同的有关挑战
六、文献述评
七、研究方案设计、统计分析计划(SAP)和选择临床试验终点所面临的挑战
八、盲法或设盲
九、主要和次要终点
十、临床试验终点的选择
十一、FDA和CE认证研究中主要终点之间的差异
十二、SAP和临床试验终点
十三、用于临床试验的SAP组成部分
商品详情

博库网旗舰店

基本信息
  商品名称:医疗器械临床试验的设计与管理(策略&挑战)(精)
  作者:(美)萨拉赫·M.阿卜杜勒-阿莱姆|责编:方金林|译者:赵大海   定 价:68   开本:16开
  出版社:中国科学技术   ISBN号:9787504690142   页数:221
  出版时间:2021-07-01   版次:1   商品类型:图书
  印刷时间:2021-07-01   印次:1   

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

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