It thrills us to help solve unusual clinical developmental and regulatory challenges.
CRS clients and partners are among the most desirable and effective life science leaders. The type of clients who choose us are those who want their own team feel without the costs, layers of decision-makers, and attrition of the big box CROs.
- e-Technology / AI / Blockchain start-ups
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
- Precision Medicine Companies
- FDA Policy Influencers
- Mid-career and Senior Professionals Seeking Placements
- Contract Research Organizations (CROs)
- Ancillary Service Providers
A special subset of our clients is involved with developing a medical product so novel, or for meeting a significant unmet need, that the path is unprecedented or regulations are incomplete. We also have clients who are changing patient monitoring and digital therapeutics with SaMD or de novo applications.
Is this Your Start-up Year?
We know your first year or two can be the most stressful. I’ve been there myself more than once. Clinical Research Strategies is giving back to the underserved Life Sciences start-up community by sharing our network and advice for your toughest decisions and problems.
We’re here to help you tackle your biggest challenges and thrive.
A sampling of a few recent clients
Respiratory / Intensive Care (COVID-19)
- US phase II clinical trial repurposing a drug for acute hypoxemia related to COVID-19
- US federal grant for SAD/MAD phase I study with inhaled biologic for COVID-19 respiratory distress
- Support for non-invasive respiratory muscle stimulator medical device
- Part of multiple grants with a regenerative medicine company that hopes to change diabetes treatment and other serious diseases
- Support for a biologics company for their phase II global trials in orthopedic trauma, whose product is a class III device in the EU
- Support for a company’s IND-enabling biologic for a rare disease in pediatric population for surgical applications
- Part of a fast-track SBIR grant and trials program with a start-up device company for Alzheimer’s disease
- Led the Q-submission for the international start-up device company for Alzheimer’s disease
- Collaboration with digital therapeutics company with multiple indications like MDD, insomnia, and general anxiety disorders
- Extensive literature review, pre-clinical / clinical development, and regulatory strategy for cannabinoid company in MDD
- IND-enabling work and regulatory agent for IND and CTA for cannabinoid company in MDD
- Phase I bi-specific antibody study with international company
- Global phase III rare disease in oncology with Canadian company
- Pre-clinical / clinical development, and regulatory strategy for cannabinoid company in opioid-sparing pain
- Clinical support and multiple literature reviews and clinical evaluation reports for company with 80+ legacy devices
- Regulatory support novel AI application and SasS for start-up
Non-Significant Risk Devices
- Non-contact monitoring device for pulse and respiratory rates clinical trials
- Non-invasive acoustic device post-CR-elective surgery
- Regulatory and clinical advice on predictive bone fracture diagnostic
- Collaboration with multiple law firms for life sciences, legal and privacy concerns, safety issues, and corporate and regulatory policy
LET’S TEAM UP TO GIVE YOU YOUR BEST SHOT AT A SUCCESSFUL LAUNCH
Contact us today for a free phone consultation.