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Medical Divice & Diagnostics Development

A dedicated center created to enhance Bioficher’ legacy and depth in cell and gene therapy research.

We bring more than 6 years of clinical trial experience, including decades of cell and gene research in collaboration with the leading investigators in the field.

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Why BioFicher?

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.

  • 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.

153

Studies Conducted

20,562+

Patients Involved

1800+

Site Worldwide

Clinical Research Experience

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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Image by John Schnobrich

Strong Relationships

  • Over 100 scientific manuscripts co-authored by BioFicher staff that encompass cell and gene therapy research results and progress.

  • Viewed as a valuable partner and collaborator by influential members of the cell and gene scientific community.

Medical Imaging

Integrated solutions based on the science of imaging biomarkers

Medical imaging endpoints can provide objective evidence of a drug’s safety and efficacy across all phases of development. BioFicher provides end-to-end integrated solutions based on the science of imaging biomarkers via cutting edge technology and image analysis tools. Our use of leading-edge technology combined with market leading expertise and best practice processes streamline the collection and management of images during clinical trials.

As experts in medical imaging and cardiac safety testing for clinical trials, we provide the ideal combination of personal service, global reach, scientific expertise, and on-time data delivery. Our core team of more than 250 qualified clinical imaging professionals includes radiologists, imaging scientists, and certified imaging technologists. These highly trained and experienced experts will provide advice on imaging endpoints and the critical uses of imaging for the medical, scientific and regulatory aspects of your trial - enabling improved clinical trial decision making and successful outcomes.

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Image by Annie Spratt

Therapeutic Expertise

  • With over 20 years of experience, our medical imaging team is the most experienced team in the industry. Our breadth of experience and expertise across phases, therapeutic areas and indications will bring real value to your clinical development programme.

  • We have extensive imaging expertise across a broad range of therapeutic areas. Managing studies in all major geographies, we have established solid working relationships with the world’s leading investigators.

Leading Edge Technologies Platform

  • BioFicher uses leading edge technology combined with market leading expertise and best practice processes to streamline the management of images during clinical trials.

  • We use market leading tools for managing clinical endpoint data collection and analysis – developed to be scalable and flexible to meet the needs of even the most complex clinical studies.

Medical Imaging Rescue studies

  • BioFicher’s rescue trial solution offers the smooth take over and seamless delivery of image analysis results according to your clinical trial schedule.

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