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Certus International Inc.

Regions
North America
Countries
United States
Size
20-50
Specialty
Human Medicines, Biopharmaceuticals
Service category
GMP audit services, GCP audit services, …
Service category
GMP audit services, GCP audit services, Quality management services, Clinical development and testing, clinical CRO, Analytical laboratory and testing services, eData - IT - software, Regulatory services - CMC writing - medical writing, Others
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Summary

Certus International is an integrated Contract Research Organization and Core Imaging Services Company offering a full range of clinical trial management, consulting and imaging services. Certus, founded in 1995, is a company whose goal is to be accessible, reliable and transparent for its clients. We do this, in part, by being flexible, maintaining a flat organizational structure, having a real person answer the phone when you call and constantly improving customer service, no matter how good you think it is. 

Evolving regulatory demands require well thought out, conscientious clinical trial designs, implemented by a dedicated and experienced clinical research team. The high-level vigilance necessary for your program requires detailed planning, oversight and execution; ensuring costs are managed and personnel motivated. Thorough planning, by forward-thinking statisticians, regulatory specialists and medical experts is invaluable to keeping your program running at the highest regulatory, ethical and clinical levels.


We believe that early collaboration saves money, hassles, headaches and time, so we support clients as early as possible, helping with GMP planning and compliance.  Our QA and CMC early trial production involvement addresses future manufacturing, scale-up processes and clinical integration. We continue support through regulatory consulting and action-oriented experts, encouraging proactive communication with regulatory authorities and compliance through solid clinical trial planning and protocol development. Often companies, especially start-up organizations, will delay involving a CRO early in the clinical development stage in order to save money by doing much of the upfront work themselves. This approach frequently leads to lost time and extra costs later that could have been avoided with early guidance by an experienced team.

The importance of properly powering your study is often not appreciated. Our experienced statisticians understand what is required and can often reduce costs and regulatory complications and frustrations, including additional trials. Our statisticians are sought after experts, established in the field, and have been requested to participate in internal FDA workshops. 

 

We also strive to maintain an excellent working relationship with the FDA. Every clinical trial we partner on is customized per the sponsor’s requested needs and our suggestions based on the experience that 123 trials and over 15 years have given us.Not all clinical research programs require a year of planning, but many do. Connect with us as early as possible to allow adequate planning time.

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