To serve our clients in saving lives. It’s all about the patients
We are an exclusive A-rated rescue organization empowered by the black belts of the biopharma. We are a focused disaster and rescue relief group of seasoned biopharmaceuticals professionals: Concentrating on major regulatory, clinical, medical, and/or operational disasters. We resolve significant findings, major 483, article 20's, consent decrees, the study holds, or safety/clinical- operational halts; no problem, contact us. We manage the end- to- end rescue mission on any major challenges. We offer immediate pipeline expansions in case of failed trials, ramp up expansions, as needed, accrual boosting measures, as well as other boosting efforts to save the day. We are not just a group of consultants; we are a team of operatives.
A Strategic Consulting focused entirely on at-risk programs in the industry. Our clients are uniquely selected. Our leading staff colleagues are uniquely trained and skilled to execute the most challenging tasks at the toughest times of any organizations. The skilled and experienced subject matter experts are on-call 24/7. For questions Please
We are the real deal AI. While Oracle speaks of open data and cloud systems to produce patient matching algorithm for clinical trials, our AI speaks to HEOR, Benefit: risk ratio, standard of care and the site’s available space to match the most patients for the best sites all at the same time.+ Read More
That means less pain in providing the site feasibility and man the inclusion/exclusion criteria. No one is as smart as we are. Let us slash millions from your clinical development budget by being smart not to cut corners by “offshore” outsourcing empty promises of the multinational corporations. We know oncology, Immune Oncology, clinical trials and drug safety in a complete GXP environment. Be accountable to the patients. Use our AI- empowering capabilities in oncology clinical trials development.
We manage all your challenges by our seasoned, thoughtful, and comprehensive oversight.
Finally, we facilitate ready to in-licensee assets and programs as needed Should your company require pipeline, life cycle R & D development projects as well as a potential cash infusion to stay afloat? Read More
A Data Monitoring Committee (DMC) is an autonomous collection of clinical professionals which monitors patient safety andefficacy data
The CEC identifies/chartered suspected events by systematic review of clinical; including biomarkers related to the events of interest,
GAP begins a risk management program with classification and evaluation of risks related to the products.
(QPPV) services for clients who are entering in the European Union (EU) market to ensure a strong administration of Marketing Authorization Holder's
SCP- Technology is a novel modality that provides enhanced solubility of chemotherapeutic agents; in addition to the class III- IV compounds,
According to the new draft Drug Safety Guidance for Industry, Biopharmaceutical and Devices companies are urged to consider utilizing Safety Assessment Committees