ELMWOOD PARK, N.J.--(BUSINESS WIRE)--LEAP Consulting Group, a boutique digital consultancy servicing the clinical laboratory industry, is excited to announce its offering for clinical laboratories already established as CLIA certified to facilitate the planning and remediation required to extend their existing CLIA, CAP, and NYSDOH CLEP to meet the expanded requirements as recently announced by the U.S. Food and Drug Administration (FDA) as part of the FDA's LDT Final Rule announcement declaration in May 2024. This offering specifically assists labs to understand their exposure, evaluate the best options to become compliant, inventory the specific gaps in their compliance posture, develop a level-of-effort and resource plan to comply, and support full remediation as advisors and implementation support as needed by labs. The key support LEAP is providing is to ensure clinical laboratories properly understand their exposure, budget properly to remediate in time for each phase-in deadline, and action the plan to meet the deadlines.
Serving clinical laboratories since 2012 and with experience meeting GXP and FDA regulations for medical devices since 2015, LEAP brings extensive expertise in diagnostics, technology, process design, implementation, and FDA compliance to transition seamlessly to meet FDA LDT medical device compliance obligations building on a lab's existing systems and processes. LEAP takes a collaborative approach to navigating the complex journey using a best-of-breed approach to adapt SOPs and where necessary support clients through buying and building right-sized digital solutions to meet obligations.
"At LEAP Consulting Group, we are proud of all of our work supporting our laboratory clients in their end-to-end digital transformation journeys from digital-front-doors through results delivery, revenue cycle, and everything in between. We are honored to be supporting our lab clients as they navigate the new requirements introduced by the FDA's LDT Final Rule." says Josh Kramer, Founder and Managing Partner of LEAP Consulting Group. Raina Kiviat, Healthcare Practice Lead of LEAP Consulting Group adds "Our expertise in diagnostics, technology, and FDA compliance uniquely positions us to assist labs in understanding their exposure, evaluating compliance options, and executing comprehensive remediation plans in a right-sized manner." Antony Galdi, Delivery Head for LEAP's implementation practice further adds "We are committed to ensuring that our clients achieve compliance efficiently and effectively, and turning these obligations into opportunities for commercial expansion leveraging this higher level of regulatory compliance. It's been a great process developing this new practice pretty quickly and navigating this new ruling together with our clients."
LEAP's process for those seeking to comply with the new FDA ruling starts with a simplified inventory and assessment and is overall a five-step process:
- Information Request: Summary of current lab systems, electronic records, change control, and reporting procedures.
- Technology Analysis: Assess systems for open/closed status to identify required security protocols.
- Gap Analysis of Processes: Identify and analyze compliance gaps in current processes and systems.
- Action Plan: Create an action plan for system configurations, policy updates, and process improvements aligned to a timeline with resourcing.
- Remediation and Adaptation: Engage teams to implement changes, create policies, and conduct training sessions.
LEAP advises on people, processes, and platforms as well as full-lifecycle technology implementation services. Varying scope and pricing options are available and LEAP can provide as much or as minimal support as appropriate for each organization.
For more information about LEAP Consulting Group's offering for labs seeking to comply with the FDA enforcement phase-in for LDTs, please visit . For general information on LEAP Consulting Group, visit .
About LEAP Consulting Group:
LEAP Consulting Group is a boutique digital consultancy that specializes in providing digital transformation services to meet complex business opportunities in the regulated industries of healthcare, telecom, and financial services. With a focus on innovation and strategic insights, LEAP Consulting Group helps organizations leverage technology to drive growth, improve efficiency, and achieve their business objectives, always in a compliant and secure manner. LEAP Consulting Group supports organizations that are transforming banking, bringing telephony to the disabled, and innovating in the world of patient care and some of the most leading-edge clinical diagnostics available.clinical diagnostics and clinical research organizations. In the clinical and biopharma human diagnostics industry, LEAP offers a full range of services supporting end-to-end digital and technology needs of the lab from digital front door, to preanalytical, lab bench process (LIMS, Instrumentation, Automation, etc), and all of the complex processes for report writing, revenue cycle, and patient engagement before and after testing. LEAP provides turnkey services starting with strategic planning through full implementation and everything in between for CLIA, CAP, NYS CLEP, and FDA compliant laboratories. LEAP's lab practice is led and staffed by veteran laboratory leaders from high volume high complexity laboratories across the United States. In addition to lab-centric capabilities, LEAP offers full capabilities across digital, cloud, and the rest of the IT ecosystems. LEAP is based in Elmwood Park, New Jersey, USA, was founded in 2010, and has been serving clinical labs since 2012.
Contacts
Robert Curtis
Head of Sales & Marketing
LEAP Consulting Group
rob@leapcg.com
+1.551.230.3840