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The most efficient path from

Study Design to Database Lock

Trusted by Big Pharma

For study design, biostatistics and data management, big pharma trusts Brightech. Since 2002, we’ve worked with over 100 clients and completed 400+ projects in all phases. Our work has been a part of 30 NDA submissions with 6 obtaining FDA/EMA approval.

Our clients are our best salespeople. Our 120+ employee company doesn’t employ a single sales representative. Our clients stay with us and we have a 95% client retention rate.

Brightech Services

Biostatistics

Statistical Programming (SAS/R)

Clinical Data Management

innovative Trial Design & Diagnosis

IDMC Services

Regulatory Submission

Medical Monitoring

Safety Monitoring and Medical Coding

Our Differentiation

Thought Leadership

Our thought-leadership in data services sets us apart in the industry. Our 10 PhD statisticians and Innovative Trial Design Group, which is overseen by KOPs, positions Brightech as the only company that knows the FDA regulation and the proper statistical approach. While other midsize BDM CROs focus on SAS programming, Brightech helps sponsors design the most efficient studies, through regulatory to the final submission package.

Study Design

70% of phase II studies fail, mostly because of study design, not the drug. Why not partner with a data driven CRO for a greater chance of success in the clinic? By taking a data driven approach with your study design, you can eliminate the design risks that are causing your competitors’ studies to fail.

Efficiency

Brightech’s proprietary approach is driven by the combination of our unique people, processes and systems that have been validated in over 400 clinical studies.

Partnership Approach

Since our founding in 2002, our CEO Dr. Tai Xie has instilled a proactive, partner-like approach for each and every project. We strive to prove that sponsors can always rely on us, so they have the assurance that their study is in good hands.

Leadership

Started in 2002 by founder and industry pioneer Dr. Tai Xie, Brightech has grown organically to 126 employees globally, with 30 in China, 16 Taiwan and 80+ people in New Jersey. We have 10 Ph.D. level statisticians who have an average of more than 16 years of pharmaceutical industry experience.

Therapeutic Areas

Brightech has extensive experience in a multitude of therapeutic areas, particularly oncology, cardiovascular disease, infectious disease, gastrointestinal disorder, CNS and analgesics; collaboration in numerous FDA/EMEA submissions.

With our expertise in complex studies, over 80% of our studies are in oncology.

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Technology

We’re experts in SAS, a certified RAVE Medidata partner and InForm. We also use CIMS, our proprietary complete EDC / eClinical solution that is unlike any other on the market.