Therapeutic for pharmaceutical, biotechnology, and medical device companies
Therapeutic Experience
Your success demands a committed and flexible partner with proven therapeutic expertise. With over 15 years of experience in consultation, design, and conduct of clinical trials, ranging from small Phase I trials to large international Phase III and IV program, Veristat’s accomplished and therapeutically-focused team of employees are dedicated to the advancement of new compounds and devices. Through its history of successful partnering with clients, Veristat has gained significant experience in the areas of oncology, vaccine, anti-infective, and analgesic studies. Further, we apply our extensive experience in electronic data capture and data submission standards to these therapeutic areas, resulting in more timely submissions in support of licensure. Out therapeutic focus coupled with our experience in innovative technologies allows us to collaborate more effectively and ultimately accelerate your product towards approval.
ONCOLOGY – Veristat has supported over 100 oncology trials in a wide range of indications from leukemias and lymphomas to solid tumors and other malignancies. The extensive oncology experience of our staff has been integral in the preparation and submission of several successful NDA and BLA filings in this therapeutic area. Further, we were instrumental in preparing our clients for, as well as presenting our clients at Oncologic Drugs Advisory Committee meetings.
VACCINES – Veristat has worked extensively in vaccine development since 1994, and in the past 5 years alone, has supported over 60 vaccine trials, including work in influenza and other infectious diseases, as well as in oncology self-vaccines. As a case example, Veristat was responsible for the data management, and statistical analyses and reporting for multiple Phase I through 3 clinical studies conducted in several thousand subjects, as well as the clinical submission, for a BLA in smallpox vaccine. Moreover we continue to support a government-funded vaccine project in partnership with a large global pharmaceutical company, proving data management, statistical analysis, and writing services.
ANTI-INFECTIVES – In the area of anti-infectives, Veristat has supported over 30 clinical trials to date and has participated in the analysis and writing support for several NDA’s for anti-infective compounds. We are currently providing data management, statistical analysis and writing support for a global Phase 3 program for a new anti-bacterial agent, as well as supporting Phase 2 and clinical pharmacology studies for the same compound.
PAIN – Veristat has been involved in over 35 studies in the evaluation of the treatment of pain including extensive experience in the conversion of CRF data from legacy studies across sponsors and countries into CDISC-compliant SDTM datasets. In the past year, our expert team has prepared the clinical summary sections and submission-ready datasets for two NDA eCTD submissions for analgesics.
Veristat's therapeutic areas of expertise include:
- Allergy
- Auto-immune Disorders
- Cardiovascular Disorders
- Diagnostic Agents
- Gastrointestinal Disorders
- HIV/AIDS
- Medical Devices
- Metabolic and Endocrine Disease
- Neurological Disorders
- Opthamology
- Reproductive Health
- Respiratory Disorders
- Transplantation
- Vaccines