Quintiles Transnational Corp.
Wholly Owned Subsidiary of Pharma Services
4709 Creekstone Drive, Suite 200
Product and Services Overview
Good science. Good service. And unmatched expertise.
Quintiles has won a reputation for getting the job done along the full spectrum of product development and commercialization activities, from early compound development, laboratory services and regulatory submission through sales and marketing. But there's more to it than meticulous procedures, innovative technology and in-depth therapeutic and regulatory expertise. You'll find we pay as much attention to customer service as to science. So, while we are certainly proud of the speed, accuracy and efficiency that help our customers succeed, we are equally proud of the long-term relationships that we have built with many customers over the years. We want you to come to us knowing you'll get the results you need. And to come back because the experience of working with us is just as rewarding as the results we deliver.
Why Choose Quintiles?
It's no accident that pharma companies, biotechs and medical device manufacturers have made Quintiles the world's leading provider of information, technology and services to bring new medicines to market faster.
Here are some of the reasons our customers give for choosing Quintiles:
Performance: At Quintiles, we know it's all about results. That's what you want. And that's what you'll get, on schedule or maybe even a little ahead of it.
Reliability: You can always feel confident working with Quintiles. The depth and breadth of our resources assure that you'll work with an experienced team whose goal is to deliver optimal results.
Therapeutic Expertise: Who's going to work on your project? Someone who speaks your language. Specialists who have backgrounds and experience like yours. With Quintiles, there's never a learning curve.
Unparalleled Range of Services: From the molecule to the marketplace, Quintiles can deliver virtually every service you need, either on its own or as part of a fully integrated preclinical, clinical, late phase and commercialization project.
Innovation: Quintiles can provide innovative business solutions that help you accelerate projects you might not have the resources to start up on your own, with sophisticated risk- and reward-sharing strategies, unusual financial structures, investments and joint ventures.
Data Management: Quintiles' foundation was built through data management and biostatistics services. Today, we continue to leverage that expertise and use both traditional tools and the Internet to deliver locked databases faster, cleaner and more efficiently.
Customer Service: Behind all the science and technology, we're in a service business. And that means every one of our people is dedicated to resolving issues, answering questions and sharing information before you ever have to ask.
Quality: Quality means getting it right the first time. Planning ahead to accelerate results. Minimizing risks. Avoiding surprises. In short, making things run smoothly from beginning to end.
Global Reach: Do you need to test a flu drug in midsummer? Select sites and recruit patients worldwide? Launch a new product simultaneously in Europe, Asia and the Americas? Chances are, we have the right people on the ground wherever you need to be.
Results: It's all about results. Quintiles has the resources -- and the right approach -- to deliver the results you need, for large projects or small, every step of the way, anywhere in the world.
Clinical Development Services
Count on Quintiles When It Counts.
Quintiles has developed a reputation for anticipating obstacles, avoiding them whenever possible and delivering real-world executions that implement the strategic thinking and careful planning behind them.
We have more depth of therapeutic expertise and a broader range of services than any other provider. In fact, we conduct more clinical trials than anyone else in the world.
And we conduct every last one of them just the way our customers want. Whether it's a big global trial or a small local project, we put you in control and give you the information you need to stay there, so you can make better decisions faster.
And that can make your clinical development project seem almost easy. Which, as you know, isn't easy to do.
Patient Recruitment Services and Solutions
Quintiles has the solutions to help customers:
- Broaden the pool of high-quality, prescreened patients
- Accelerate the patient recruitment process
- Increase the throughput of patients during the enrollment process
The primary reason clinical trials fall behind are:
- Patients have limited access to study opportunities
- It is difficult to motivate patients to switch from an already existing therapy
- Competing protocols mean there are only a limited number of patients available to participate in studies
- There is poor planning regarding study start-up
By using Quintiles' services, customers can identify patients and physicians more quickly.
Data Management and Biostatistics
Data Management That Makes Data Meaningful
The goal is always the same: Generation of a clean, fully integrated scientific database, ready for statistical analysis and in full compliance with regulatory guidelines. It's how Quintiles gets there that makes the difference.
Before we even begin to capture data, Quintiles focuses on the questions that need to be answered and the goals that need to be achieved. That way we know up-front what data to collect and how to organize it during the collection process.
Then we choose the most appropriate technology - from traditional tools to the Internet - to capture and store the data with optimal speed and quality. At every stage, our data managers translate the sometimes messy realities of data from the field into the clean, clear database demanded by biostatisticians and their computers. From the initial handling of case report forms to completion of the database, our standard operating procedures assure a degree of worldwide consistency, completeness and accuracy that exceeds regulatory requirements.
And that's what makes the difference between a confusion of numbers and a clear interpretation of outcomes.
Quintiles Biostatistics - A Strategic Advantage
Quintiles was founded by biostatisticians, and as you might expect we have amassed statistical experience in all therapeutic areas, all along the product development continuum. Our analytical capabilities are everything you'd expect, and the quality of our service is assured by a dedicated team of epidemiologists, biostatisticians, statistical programmers and support staff.
But we have also learned that, working creatively with your biostatisticians, physicians, medical writers and regulatory personnel, we can create strategic advantages that decrease costs and accelerate timelines through optimum decisions on sample sizes, numbers of studies and precise interpretations and presentations of results.
We can also leverage the power of biostatistics to develop innovative study designs, clinical development programs, analysis methods, data displays and interpretations.
We start out with the end result in mind.
The first step in every Quintiles biostatistics project is to define the goal and form of the final statistical analysis. In fact, our biostatisticians become involved with projects at the earliest protocol development stage, to advise on the design, size, and conduct of the study.
Once the data are gathered and stored, Quintiles' biostatisticians put their experience to work analyzing and interpreting the results. The result is everything it should be: professional, focused, fully documented, and verified -- and fully compatible with your reporting requirements.
Quintiles Laboratories is a global Central Laboratory committed to providing fully integrated clinical laboratory services which support all phases of both global and regional clinical trials, while retaining a strong emphasis on patient care.
We offer one of the broadest areas of geographic coverage in the industry with owned facilities in the U.S., Europe, South Africa and Singapore and sub-contract facilities in Brazil, Argentina and Australia.
When working with Quintiles Laboratories, sponsors get standardized implementation, analytical testing and database development and transfer. A dedicated team assists in the design, implementation and closure of the laboratory component of phase I - IV clinical trials.
Our dedicated global and regional project management works within the clinical research team structure to minimize the need for sponsors to manage the laboratory component of a project. Our built in, high quality processes assure the on-time transfer of an accurate, verifiable and integrated database.
Clinical Supplies and Manufacturing
The Capacity to Supply for Any Clinical Trial
Our service covers the clinical supply process from clinical manufacture to drug destruction in quantities ranging from Phase I and compassionate use requests to large-scale Phase III/IV studies involving multinational centers. It includes packaging, labeling, and distribution services for patient administration at investigator sites worldwide. When it comes to driving project completion, Quintiles provides unsurpassed attention to detail.
Manufacturing - The Capacity to Manufacture on Any Scale
Quintiles has the resources and developmental capabilities to expand small-scale processes for clinical trial batches into full-scale commercial production. This ability to transfer technology is important. As your compound advances toward commercialization, Phase III batches of a compound need to be manufactured similarly to the way they will be manufactured commercially. Quintiles can do this while offering many manufacturing options.
Regulatory, Safety and Compliance
Regulatory Affairs: Guiding Principles, Not Just Final Results
At Quintiles, our regulatory and safety oversight services are a seamless part of the drug development process from beginning to end. Because our staff have experience and rapport with many FDA and European regulatory agency divisions, they can explore with clients the shortest route and timeframe to bring their products to market. We know what issues are likely to come up and can develop strategies to address them early on. In addition, our knowledge of local market requirements throughout the Americas, Europe, and the Asia Pacific region gives you the advantage of submitting registration applications simultaneously in any regions that interest you
We start out with strategic regulatory, scientific, and safety planning in the preclinical phase. By designing a study that integrates a full understanding of current regulations and the regulatory environment from the start, we can help assure that the whole drug development process runs more smoothly and efficiently.
We also provide worldwide coordination of clinical and post-marketing safety data collection, processing, and reporting.
Last Updated: 12-14-04
Quintiles Transnational Corp.