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Clinical Operations

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From start-up to close-out, our experienced clinical operation teams ensure efficient site support, patient safety and data monitoring through a complete project management system and effective relationships with widely distributed study sites. Our wide network of clinical experts ensures global consistency and high standards that meet ICH-GCP guidelines, wherever we manage your clinical trials.

Besides a focus on quality, our high-skilled, knowledgeable teams aim to ensure that your clinical trials are executed efficiently and cost-effectively, and are ready to partner with you to develop a program customized to your needs.

 

Medical Science

Tigermed’s medical department is composed of numerous highly qualified clinical experts and a trained auditing team, which has a sound quality management and quality control system to ensure compliance with both ICH-GCP and Chinese GCP requirements during your clinical trials. The team has a proven track record in obtaining high-quality clinical research data and meeting the various expectations of international and domestic clients in clinical development.

 

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Early Clinical Development

Phase I / First in Man

Our teams collaborate closely with you to develop tailored roadmaps for your study and aim to maximize efficiency, anticipate challenges, and mitigate risk. Our phase I strategies to minimize the time spent on reaching a key go/no-go decision by leveraging our many clinical facilities, biometrics capabilities, PK/PD study experts, and project management experience. This Is all part of the Integrated Technology Services that Tigermed has developed to ensure rapid and high-quality data collection, analysis, and reporting to the benefit of our clients’ clinical development programs.

Phase IIa

We always start with the end in mind and successful studies should have a high degree of flexibility as to answer questions early to avoid unnecessary investment at later stage. Answering these meaningful questions in modern clinical trials is facilitated by our advanced skillset in biometrics to help you generate the clinical evidence you need.  Additionally, we have a proven track-record of enrolling suitable and usually hard-to-find patients for specialized trials thanks to our dedicated recruitment centers.

 

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Late Phase Development

Phase IIb / Phase III

These sheer size of large trials means increasingly complex study designs, evermore challenging subject enrollment, and demand for therapeutic knowledge. Modern successful trials implement adaptive clinical trial designs, make use of experienced clinical operations staff, advanced PK/PD and biometrics, all of which Tigermed has to offer tailored into a solution that fits your needs.

By making use of our robust in-house quality management system, well-developed SOPs, extensive experience in international project management, we have executed numerous large-scale trials efficiently and cost-effectively.

 

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Medical Monitoring

Our Medical Affairs team is composed of clinical physicians with specific expertise and abundant experience in clinical trials. Regarding to ICH-GCP and Chinese GCP regulation, we have a well-established medical monitoring management system to ensure the subject safety, the medical compliance with the protocol and ICH GCP requirement, and the scientific integrity, which can guarantee the high quality of clinical trials and meet the expectation and requirement of international and domestic clients in the field of medical monitoring and medical consultation service.

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Project Management

One-Stop Shop for Project Management

Besides our experience in various projects, we also apply our company values in our project management. We aim to be flexible, innovative, respectful, and honest. By doing so in all our activities globally and in a broad spectrum of therapeutic areas, help you to successfully navigate any hurdle in clinical development. Our project managers are professionals who respect authorities, clients, colleagues, and all those we collaborate with to deliver high-quality results that matter. They will share expert-level and transparent advice to provide you with any information that is required for science-based decision making.

 

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Patient Recruitment

Overcoming Hurdles in Enrollment

With the development of technology and health care reform, the recruitment and entry of patients has become the most critical factor affecting the quality and progress in current clinical trials.

 

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Quality Management System

Assuring Quality in Clinical Development

Clinical Trials are subject to a broad spectrum of quality requirements including aspects like distribution, labelling, packaging, and release by a qualified person. Our specialists can help you set up, design, and/or improve your Quality Management System (QMS), providing your clinical development with a solid structure in terms of Standard Operating Procedures (SOP), processes and resources that allow you to streamline your clinical trials and cost-effectively mitigate potential quality issues.

It is their vast clinical experience that enables our clients to identify and prevent issues that might otherwise turn into major bottlenecks at a later stage. And, because there are often different third parties involved, our quality experts also help to mitigate the quality and risk of vendors to your clinical trial operations by providing audits, comprehensive staff training, and accurate SOP management.

 

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A Proven
Clinical
Network

Thanks to Tigermed’s position as the leading CRO in China, we are able to offer a broad network including research institutes, hospitals, and thought leaders in clinical development.

Recruitment
Center
Services

Patient entry has become the most critical factor for quality and success. Tigermed specialized recruitment centers have a proven track record of patient enrollment.