Tigermed Insight

Beyond Borders: Pioneering Global Clinical Trials for 20 Years and Counting

Jan 03, 2024

Beyond Borders: Pioneering Global Clinical Trials for 20 Years and Counting

Push the Boundaries of Clinical Research with Tigermed

 

The past 20 years has seen a major shift towards globalized clinical trials. For sponsors, the benefits are clear: multinational trials are more cost-effective, facilitate global commercialization, and often boast faster completion timelines. That’s why roughly 80% of approved marketing applications for new drugs include data from multi-national sites.

 

Entering a worldwide market can also present its own challenges, as many sponsors have experienced. Coordinating trial sites across multiple countries adds another level of communications, project management, supply chain considerations, regulatory compliance measures, and data management. Many countries worldwide have experienced a decline in trials since 2021, making choosing a reliable and experienced research partner a key factor for successful clinical development.

 

While the United States dominate clinical trials globally, China also represents a top location in recent years. As a matter of fact, China has been leading the world in total number of newly started clinical trials since 2021(1). Globalization has catalyzed explosive growth for global clinical research organizations (CROs) with footholds in China, leading to innovation in clinical trial execution and management.

 

From this period of growth, Tigermed has emerged as a leading global provider of integrated research and development (R&D) solutions for the biopharmaceutical and medical device industry. Our integrated approach spans a broad portfolio of services across preclinical, clinical, regulatory, and post-marketing stages. We are committed to empowering R&D pipelines, maximizing efficiency, accelerating product commercialization, and addressing unmet patient needs to improve human health.

 

As our Co-founder, Dr. Xiaochun Cao, shares, “The ever-growing globalization of clinical trials presents challenges, but it also opens avenues for progress. At Tigermed, we embrace the unique needs of each trial and use our passion for innovation to propel science forward.”

 

Read more below to discover what you can expect when partnering with us.

 

 

The Tigermed Advantage

Our capabilities span many sectors, from medical translation to pharmacovigilance and more. Established in 2004, we have spent nearly 20 years creating integrated solutions to drive healthcare innovation forward.

 

 

Global Recognition in Research Excellence

Finding an experienced thought partner is a top priority for any sponsor spearheading a multi-national trial. In meeting this need, sponsors can confidently turn to Tigermed for assistance.

 

As the leading clinical service provider in China and the only China-based CRO ranked in the top 10 worldwide in 2021, Tigermed has garnered global recognition for research excellence. We’ve assisted over 2,800 clients to date, and involved in the development and regulatory of 92 approved Class-1 innovative drugs in China. Sponsors looking to move their trials into the global market can rely on us for experienced guidance and thought partnership. In the 700+ innovative drug clinical trials we’ve managed, over 120 have spanned multiple regions. That’s experience our clients can count on.

 

 

Comprehensive Trial Solutions

Full-service offerings can provide many benefits for sponsors, including streamlined processes, quality assurance, and better risk mitigation. Engaging a research ecosystem like CROs saves sponsors time and budget in moving their trials forward.

 

We offer integrated one-stop solutions for pharmaceutical and medical device trials, culminating in over 3,500 total drug and 830 medical device studies across various disease areas. From oncology to vaccines to rare diseases, our experts have it covered.

To support these efforts, Tigermed provides an array of end-to-end services for all of a sponsor’s trial needs. Check out our expansive offerings here.

 

 

Delivery with Quality & Speed

Clinical trials are an extensive undertaking that requires a significant time commitment and can easily go off a proposed completion timeline. Roughly 80% of clinical trials report delays worldwide, most often when it comes to meeting patient enrollment deadlines.

 

Sponsors can maintain momentum by aligning with a CRO partner that offers continual guidance and consistently delivers high-quality work within an efficient timeframe. That’s why our team prides itself on memorable, world-class customer support. We offer around-the-clock resourcing, ensuring our partners always have a point of contact to connect with.

 

“The Tigermed US team has done a great job planning and executing on our Phase III. The team is quick to respond, accountable for their actions, and flexible to change directions and priorities on short notice. Good project management experience and a dedicated staff were the keys to success on our project.”

---Vice President of Clinical Operations at a U.S.-based biotechnology company

 

At Tigermed, sponsors are our top priority. That’s why we tailor our approach to each client, customizing standard processes and adapting to the unique needs of every trial. This agility is enabled by an integrated team strategy, bringing together individuals from across functions into one team. We work together as one, not as different silos, for seamless collaboration and to streamline project execution.

 

Our approach values flexibility and cost-effectiveness while ensuring maximum efficiency and fast delivery. To this end, we have created synchronized platforms for managing biometrics in even the most complex clinical trials. Our industry-leading data management, biostatistics, and statistical programming processes have spanned over 4,500 completed projects and 30 new drug and biologics license application submissions to the FDA with new indications.

 

 

Multinational Support Network with Local Expertise

Multi-national trials require support that extends to every possible site location, from local knowledge in China to global knowledge across the United States, the United Kingdom, and more.

 

Tigermed maximizes client support by leveraging a comprehensive network of experts and operational capabilities in APAC, Europe, the Americas, and Africa. That’s over 180 locations in 30+ countries globally.

 

Our extensive knowledge in multiple markets has helped many partners optimize their trials. For example, we assisted a sponsor aiming to start a Phase I oncology trial for a therapeutic targeting human epidermal growth factor receptor 2 (HER2). The client faced several challenges because of the competitive landscape for HER2, restrictions in China during COVID-19, inflation and resourcing issues in the US, and an impending holiday season.

 

We took several steps to navigate these challenges and stay true to the client’s timeline. First, we submitted it to the Food and Drug Administration (FDA) and the Central Institutional Review Board at the same time to hasten regulatory review. Concurrently, we leveraged our established network to quickly locate trial sites while awaiting final approvals. This approach enabled us to have the first site ready only six weeks after receiving the final protocol.

 

Under one protocol, the multi-national study established sites in the U.S., China, and Australia. These countries were strategically selected for their faster startup of Phase I trials, aiding the team in successfully meeting milestones and navigating the challenges presented.

 

 

Regional Capabilities

Check out our service networks across the globe below.

 

North America

Our North American operations feature a dedicated local team to ensure expertise across all aspects of clinical trials. With laboratory facilities in eight cities and partnerships with over 100 sites across 33 U.S. states, Tigermed has established a robust presence in the region. We are committed to local proficiency and a comprehensive approach to research, encompassing clinical monitoring, project management, biometrics, site management, and regulatory affairs.

 

China

The China-based Tigermed team is nearly 8,000 strong and engaged with over 1,300 clinical sites — a central hub for global operations and resources, representing the largest clinical CRO in the country (2). Our 12 state-of-the-art laboratory facilities provide full research services for clients across pharmaceuticals, biotech, and medical devices.

 

APAC

Our teams stretch across over a dozen countries in APAC, with offices strategically positioned in Japan, Korea, Australia, and Southeast Asia. We bring extensive experience to the forefront, particularly in the execution of large-scale clinical studies. Our local expertise in clinical operations, project management, and biometrics are a reliable resource for any client looking to extend their trials into this region.

 

EMEA

Tigermed's footprint in Europe is marked by a dynamic team spread across 15 countries, comprising a full organization and supporting functions for the entire EMEA region. Our localized knowledge extends from Eastern to Western Europe and into Africa, providing us with a comprehensive understanding of diverse clinical landscapes throughout the region. With expertise in clinical operations, regulatory affairs, pharmacovigilance, and site management, we are well-equipped to cater to the unique needs of the European market and beyond.

 

 

Looking to the Future

Ready to explore how Tigermed can elevate your clinical trial to new heights? Click HERE to schedule a meeting with us today.

 

Or you can find out where to meet our clinical and regulatory experts at global events and conferences HERE.

 

 

Note:

(1)Source: Insight Database

(2)Source: Frost & Sullivan 2023 Report