Guiding You Through The Pre-Clinical Process
In a world of quality by design, B.Z. Research Solutions brings solid experience and expertise in Research & Development at the Pre-Clinical stages.
Through a detailed assessment process, supported by our accompanying experts team, we will actively manage the entire process with you, and provide you with a broad perspective of the overall needs of your development, from design to performance.
Our Services Include
The extensive background of our team, coming from different niches of the development process, allows us to tailor the optimal and cost-effective solution that responds to your product needs. With extensive experience as a Pre-clinical GLP facility manager and as study directors in both GLP and non-GLP studies, and with a prior background in a medical device startup company, along with the bio-medical engineering aspect, we have deep understanding of the pre-clinical steps. B.Z. Research Solutions can provide you close consultation services that include tailoring development plans to suit your particular product needs, design and execution of experiments and technical writing.
We design and monitor each step of the process, including:
- Establishment of animal models
- Ethical requests
- Identifying the appropriate research facility/laboratory
- Designing a high-quality Study-Protocol, Forms, CRFs
- Continuous contact with the research facility and the teams
- Hands-on participation in the study
- Data and results collected during the study
- Data management and analysis
- Designing a high-quality Study-Report as a part of a comprehensive study file.
Comprehensive Strategic Planning
Research & Development plan
Designing effective regulatory strategies
Scientific Advisory Services
Animal model establishment
Bench testing (In-vitro / ex-vivo models)
Whether it’s GLP, GMP, ISO or Medical Cannabis Permit for research, we will accompany you through the entire process, until achieving the desirable accreditation.
Quality Assurance System
Establishment, upgrading or adjusting of a quality assurance system, including building all SOPs, forms, plans, internal and external audits, training, etc.
Tailoring of the facility and the equipment to the requirements of the requested standard.
Processes / Studies
Accompanying critical processes, ongoing procedures, and studies (as part of the submission to regulators).
Developing your organizational independence without reliance on on-going consultation
Recognized by ISRAC
We work closely on a continuing basis with regulatory / accreditation authorities (including ISRAC).
Business Oriented Services
Access to potential project-oriented financing sources, including managing the capital-raise process.
Access to Global Network
Access to a global network of dedicated professionals in all fields relevant to the preclinical and clinical process stages, local and worldwide: consultants, service providers, facilities (GLP/non), collaborations
Supervising and managing the external due-diligence process, including establishing and managing DD Data Rooms. Whether the due diligence is required as part of a capital-raising campaign or M&A (Mergers and Acquisitions) transaction, speed is the key success factor for viewing and managing documents. A cleverly planned program will increase the likelihood of a speedy and successful closing.
Supporting grant application process
Access to global network of dedicated professionals in all fields relevant to the preclinical and clinical process stages.
Co-Founder & CEO
Gadi brings to the table eight years of experience as the GLP unit manager in GLPigs (the Pre-Clinical R&D Unit of Assaf-Harofeh Medical Center), including as Study Director of over dozens of studies (both GLP and NON-GLP) in multidisciplinary areas of the biomedical development. Gadi also served as a member of the Ethical Committee of the Assaf-Harofeh Medical Center. Prior to joining GLPigs (Assaf-Harofeh) Gadi spent over five years at TransPharma Medical, working as part of the Pre-Clinical team that developed a combined device for transdermal delivery of drugs. Gadi has a B.Sc. in Life-Sciences from Tel-Aviv University, and has done post-graduate work in the Neuro-Biochemistry department of Tel-Aviv University, as a part of M.Sc. studies. read more..
Co-Founder & Consultant
Assaf has several years of experience including as Study Director of dozens of studies in multidisciplinary areas of the biomedical development. Assaf also served as a member of the Ethical Committee of the Assaf-Harofeh Medical Center. As a Bio-Medical Practical Engineer, Assaf worked in Assuta Medical Center, where he provided professional engineering support and related services for surgical suits. In addition to his experience in building experimental animal models, Assaf brings engineering insights which are important to and need to be integrated in the development process. read more..