BioStrategics Consulting
BioStrategics Consulting Ltd, founded in 1999, provides management-level clinical development consulting services to the pharmaceutical, biotechnology, and medical device industries. Their services include clinical development strategy, IND planning, clinical trial management, regulatory submissions, and advisory services. They have a proven track record of leading over 25 regulatory submissions, numerous first-in-man trials, and strategic consulting projects worldwide. Their mission is to help clients transform molecules into valuable corporate assets through strategic, scientific, and operational excellence.
Industries
Nr. of Employees
small (1-50)
BioStrategics Consulting
Marblehead, Massachusetts, United States, North America
Products
Clinical Development Consulting Services
Management-level clinical development consulting services provided to the pharmaceutical and biotechnology industries.
Clinical Development Consulting Services
Management-level clinical development consulting services provided to the pharmaceutical and biotechnology industries.
Services
Strategic planning of clinical development programs and registration pathways to align clinical activities with corporate objectives.
Preparation for IND/CTA filings and planning for first-in-human and proof-of-principle studies.
Creation and review of protocols and Investigator Brochures tailored to answer key scientific and regulatory questions.
Evaluation and operational management of external contract research organizations and other vendors.
Provision of medical monitoring, adverse event evaluation, and oversight during conduct of Phase 1 and Phase 2 trials.
Analysis and presentation of trial results for internal decision-making, investor briefings, and regulatory interactions.
Strategic planning of clinical development programs and registration pathways to align clinical activities with corporate objectives.
Preparation for IND/CTA filings and planning for first-in-human and proof-of-principle studies.
Creation and review of protocols and Investigator Brochures tailored to answer key scientific and regulatory questions.
Evaluation and operational management of external contract research organizations and other vendors.
Provision of medical monitoring, adverse event evaluation, and oversight during conduct of Phase 1 and Phase 2 trials.
Analysis and presentation of trial results for internal decision-making, investor briefings, and regulatory interactions.
Expertise Areas
- Clinical trial management (Phase I/II and first-in-human)
- IND/CTA and regulatory submission strategy
- Protocol development and Clinical Investigator Brochure authoring
- Medical monitoring and pharmacovigilance for early-phase trials
Key Technologies
- Clinical trial design and protocol development
- IND/CTA regulatory submission workflows
- Pharmacokinetic (PK) and pharmacodynamic (PD) assays
- Medical monitoring and adverse event evaluation
News & Updates
Strategic Success Case: Scandinavian Healthcare Company
Evaluation and strategic planning for diversification into pharmaceutical business, leading to the development of an innovative pharmaceutical unit.
Operational Success Case: Small Molecule Receptor Agonists
Assisted a start-up in Phase 1 trial planning, site selection, and clinical oversight, resulting in successful data collection and strategic corporate decision-making.
Scientific Success Case: Anti-Cancer Vaccine Development
Helped design a Phase 2 protocol for a novel vaccine, incorporating unique features and ensuring scientific and regulatory acceptance.
Expert Testimonial: Simona Cipra on Dr. Silverman
Praise for Dr. Silverman's clinical design skills and operational approach in oncology biologic development.
Support for Pharmalucence
Support in clinical trial design, FDA submission, and medical director roles, with high impact and collaboration.
Innate Immunotherapeutics Endorsement
Long-term collaboration and high recommendation from the CEO for strategic and operational contributions.
Strategic Success Case: Scandinavian Healthcare Company
Evaluation and strategic planning for diversification into pharmaceutical business, leading to the development of an innovative pharmaceutical unit.
Operational Success Case: Small Molecule Receptor Agonists
Assisted a start-up in Phase 1 trial planning, site selection, and clinical oversight, resulting in successful data collection and strategic corporate decision-making.
Scientific Success Case: Anti-Cancer Vaccine Development
Helped design a Phase 2 protocol for a novel vaccine, incorporating unique features and ensuring scientific and regulatory acceptance.
Expert Testimonial: Simona Cipra on Dr. Silverman
Praise for Dr. Silverman's clinical design skills and operational approach in oncology biologic development.
Support for Pharmalucence
Support in clinical trial design, FDA submission, and medical director roles, with high impact and collaboration.
Innate Immunotherapeutics Endorsement
Long-term collaboration and high recommendation from the CEO for strategic and operational contributions.