The State of Preclinical Studies: A Q&A with GCMI’s Director of Scientific Affairs Evan Goldberg

Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…

Why GCMI for preclinical testing and bioskills training? Commitment to value.

We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice.   Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all…

Why GCMI for preclinical testing and bioskills training? Our scientific acumen.

At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA.    We won’t turn your project away because it’s too hard, or because we haven’t done…

Why GCMI for preclinical testing and bioskills training? Quality, compliance and accreditation.

At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers.   GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services.…

Why GCMI for preclinical or bioskills training? Collaborative accountability.

In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols.   Why choose GCMI for your preclinical testing needs? We are collaborative and accountable. We are committed to meeting your needs on your timeline and on your budget.  …

Why GCMI for your preclinical or bioskills programs? Flexibility.

As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not…

Preclinical testing’s role in the medical device design and development phase

In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and Development…

How do you know you are ready for preclinical work? Join us for a free webinar on January 14.

Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions.  But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat.   How…

Behind the scenes: what it takes to keep an industry leading preclinical CRO running right

GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards  for our medtech and life science customers. …

What is verification and validation in medical product development?

Medical product design verification and validation activities (called “Phase 3” and “Phase 4” at GCMI) typically come after a design phase (called “Phase 2” at GCMI). At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this…