Veristat, a full service consultative Clinical Research Organization (CRO), has announced the formal launch of its Strategic Decision Consulting service offering to help pharmaceutical, biotechnology and medical device firms solve the unique and complex challenges they face throughout the development process. Veristat will provide clients with the knowledge, foresight and expertise to make informed strategic decisions in order to accelerate their therapies through development.
“Many of Veristat’s clients have come to trust the intellectual leadership and guidance that our senior clinical trial professionals provide as we help our clients progress through clinical development,” stated Patrick Flanagan, Chief Executive Officer of Veristat. “The Strategic Decision Consulting service is a culmination of client demand for strategic level thinking to optimize decision making for their clinical development approaches, trial designs and regulatory submission strategies.”
Veristat’s Strategic Decision Consulting service is being led by Veristat Co-Founder and President, John Balser, PhD.
“For over 20 years, my colleagues and I have offered a wealth of scholarly and operational advice to support our clients’ strategic as well as tactical decision making throughout the design and implementation of their clinical trials and regulatory submissions. We are formalizing this offering to provide our clients with the appropriate clinical, medical and regulatory expertise earlier in the decision making process for their individual trials and complete development programs.” stated John Balser, PhD, President of Veristat, “Our goal is to evaluate and implement strategic, operational and technical efficiencies for the advancement of clinical trials research methods and regulatory submission strategies, to accelerate drug and device regulatory approvals through early engagement of optimal clinical development plans and trial designs, and to provide intellectual leadership both internally within Veristat and externally to our clients. This team is well equipped to logically conceptualize critical issues and solutions, and drive these concepts to operable conclusions.”
The consulting team is comprised of biostatisticians, clinical and pre-clinical scientists, physicians, regulatory specialists and medical writers. Service offerings include:
- Advanced and adaptive clinical study designs
- Predictive modelling and clinical trial simulation
- Clinical development plans
- Advanced analysis plans for submission summaries
- Regulatory strategy