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Commercial Compliance

BioFicher’s advanced compliance solutions intelligently unite and enhance the effectiveness of disparate elements within your compliance program, fostering a more seamless integration. 

Understanding the internal and external factors in life sciences compliance that will accelerate efficiency.

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Regulatory Compliance

Proven Expertise

  • More than 120 research studies aimed at addressing questions using cell or gene therapies for various therapeutic areas including hematology/oncology, ophthalmology, cardiology, and pulmonology.

  • A full array of research services: clinical trial operations, study leadership, statistical services, and pharmacovigilance, along with regulatory, training, and educational support.

  • Depth and breadth of cell and gene therapy credentials and experience at all levels.

Quality Compliance

Proven Expertise

  • We conducted cell and gene therapy research for biopharma, biotech and public sector clients for more than 5 years.

  • Established early leadership in the field of cord blood research, starting in 2016. Participated in the first multicenter study aimed at evaluating whether human leukocyte antigen mismatched, unrelated umbilical cord blood stem cell and progenitor cell units offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation in patients with malignant and non-malignant disorders.

  • Completed the groundbreaking Age-Related Eye Disease Study (AREDS) , which began in 2016, and the subsequent AREDS 2 trial, resulting in today’s widely available vitamin supplements that can help delay progression of macular degeneration.

  • Studied the effect of graft-versus-host disease prophylaxis as part of a Phase 2 and 3 trials in recipients of unrelated donor bone marrow in 2017.

  • Designed and managed several first-in-human studies of various cell types for infusion into patients with cardiac heart failure, beginning in 2017.

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Safety and Pharmacovigilance

Meeting your compliance objectives in a world of constant change and financial challenges means doing things differently. It requires automating, adopting advanced technologies, and leveraging outsourcing.

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Staying on top of drug safety.

Drug safety and pharmacovigilance professionals are increasingly challenged, having to do more with less. The key to your success is implementing automation, adopting advanced technologies, and leveraging insights from analytics that improve compliance and product safety. IQVIA provides flexible, innovative, scalable solutions to meet your unique business requirements.
 

Cell & Gene Therapy Leaders

At BioFicher, we value the open exchange of communication between our therapeutic area leaders and your team. We encourage you to contact us to discuss your research plan and determine how we can support your development pathway.

Tom Carnon, Ph.D.

Chief Research Officer

Mary Clemons, Ph.D.

Director and Biostatistician, Ophthalmic Therapeutic and Research Unit

Satisfaction Guarantee

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