A highly qualified physician-scientist, a founder of VitaWay Research LLC, with a deep understanding of the industry and drug development, knowledge of clinical development guidance and regulatory requirements, decades of practical clinical development experience leading and executing R&D oncology projects in hematologic and solid tumor malignancies, offers and provides a medical consultant service dedicated to early- through late Phase I-IV clinical development
Areas of expertise
- Hematologic and solid tumor malignancies, endocrinology, and internal medicine.
- Strategic and operational trial planning, study design, protocol development, feasibility, study initiation, conduct, execution, study closure, submission, and approval
- Leadership, oversight, medical monitoring of US and global clinical trials
- Clinical, safety, efficacy data review, evaluation, interpretation, analysis, reporting
- Design, implementation of medical review & safety monitoring plans, DMC charter, imaging charter, required study documents
- CTCAE, MeDRA, medical coding; tumor assessment evaluation per RECIST, mRECIST, Lugano Classification, Owen criteria
- Support with development of ICF, eCRF, RAVE, EDC, TLFs, intext-tables
- Team trainings, presentations at investigator’s meetings
- Study data analysis, presentation to Data Monitoring committees (DMC), Steering committees (SC), Safety committees, Advisory boards, internal/external stakeholders
- Integrated clinical, safety, efficacy analysis and clinical study reports (CSR)
- Collaboration with trial multifunctional teams for timely milestones delivery, data integrity, risk management, data quality control
- Interactions with FDA, EMA, health / regulatory authorities, ECs, DMCs, SCs, KOLs
- Medical support with IND, NDA, ODD submissions, PMRs, Investigator’s brochure
- Mentor and support trial teams, clinicians, junior colleagues
- Knowledge and compliance with ICH, GCP, and regulatory requirements
- Publications and peer review
Company Details
- Founded
- 2022
- Address
- 2 Schindler Drive, Randolph,new Jersey 07869,united States
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- Clinical development, Project Leadership, Phase I-IV clinical trials, Medical monitoring, Safety review, analysis, reporting, Protocol development, Regulatory submissions, Study design, Efficacy review (RECIST, mRECIST, Lugano, Owen), Trial initiation, execution, closure, submission, approval, Hematologic and solid tumor malignancy, Risk management, DMC, safety committees, Investigator’s meetings, Trial oversight, Safety and Clinical Study Reports (CSR), Interactions with FDA, EMA, HAs, Compliance with ICH, GCP regulatory requirements, Publications, peer review, IND, NDA, ODD submissions, Data integrity, quality control, Medical expert, Oncology, CRO, RAVE, eCRF, Integrated safety analysis, Drug Label, Post marketing report, Investigator’s Brochure, Safety run-in, DLT, Trial eligibility evaluation, TLF, intext-tables, subject narratives, CTCAE, MedDRA, medical coding, US and global clinical trials.
- HQ
- Randolph, New Jersey
- Competitors
- JACQUES GUERCY WEICHERT REALTORS 845-641-4542 or jguercy@gmail., illuminatih1222@gmail.com, Bradford Medical Consulting LLC, JPK Medical Consulting, K.J.SALTPETRE (MANUFACTURER OF POTASSIUM NITRATE & MAGNESIUM CHLORIDE) +91 9444842216 (OR) +91 9445179207, kjsaltpetre@gmail.com, United Medical Consulting, Argent zaher nourredine nzaher81@gmail.com Energy Inc., D & A Medical Billing & Consulting Inc, Supporting All Students Educational Consulting, LLC (saseducationalconsulting@gmail.com), TIMSTOOLZ@gmail.com.
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@gmail.com Questions
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@Gmail.Com's LinkedIn profile is https://www.linkedin.com/company/vitaway-research-llc
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@Gmail.Com's industry is
Biotechnology Research
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@Gmail.Com's top competitors are
Jacques Guercy Weichert Realtors 845-641-4542 Or Jguercy@gmail.,
Illuminatih1222@gmail.com,
Bradford Medical Consulting Llc,
Jpk Medical Consulting,
K.j.saltpetre (Manufacturer Of Potassium Nitrate & Magnesium Chloride) +91 9444842216 (Or) +91 9445179207, Kjsaltpetre@gmail.com,
United Medical Consulting,
Argent Zaher Nourredine Nzaher81@gmail.com Energy Inc.,
D & A Medical Billing & Consulting Inc,
Supporting All Students Educational Consulting, Llc (Saseducationalconsulting@gmail.com),
Timstoolz@gmail.com.
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@Gmail.Com's categories are Biotechnology Research
Vitaway Research Llc. Medical Consulting Services Email: Vitawayresearch@Gmail.Com's founding year is 2022
