BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost savings. We partner with domestic and international, small-to-medium drug and device companies that are entering early clinical development. BBCR is dedicated […]
Real World Evidence
BBCR Streamlines Clinical Development with the Clinical and Regulatory Expertise to Support Your Development Needs
May 28th, 2020 | Real World EvidenceThe future of Orphan Drug Clinical Trials
May 4th, 2020 | Real World EvidenceBiotech companies’ continued participation in the Global Orphan Drug Market Opportunity requires the development of new strategies rooted in the established knowledge of orphan developer experts. Participation of big pharmaceutical companies in the ongoing clinical research of orphan drug are about to introduce a drastic change in overall scenario of the approach. Global Orphan Drug […]
First Coronavirus deaths reported in indigenous communities that live in Amazonia (National Geographic).
April 28th, 2020 | Real World EvidenceAt least 28 communities living in extreme isolation in the Brazilian Amazon, and there may be as many as 80 more, have confirmed to be in existence. On April 9, a Yanomami adolescent had died of COVID-19 in the northern state of Roraima. The youth had moved back and forth through an area rife with […]
FDA approved mesenchymal stem cell (MSC) treatments as compassionate use in the very sickest COVID-19 patients.
April 22nd, 2020 | Real World EvidenceA pilot study in China in which seven COVID-19 patients received intravenous infusions of donor mesenchymal stem cells (MSC) indicates that the intervention was safe, and that the approach may improve infection outcomes was reported in Aging and Disease last month. We understand that it is only a small number of cases, and studies in […]
Saliva Test for COVID-19 reduces health care professional risk of infection
April 15th, 2020 | Real World EvidenceSaliva Test for COVID-19 Approved for Emergency Use by FDA on 13 April 2020. Saliva testing will help with the global shortage of swabs, increase possibility of people testing, and reduce risk to collect samples by health care professionals. The saliva-based test requires saliva collection by subject spitting several times in a given plastic tube. […]
COVID-19 Global Pandemic disruption in RARE DISEASE clinical research
April 14th, 2020 | Real World EvidenceThe COVID19 has taken the world by a stranglehold and the outbreak is causing significant disruptions in clinical research which is facing significant challenges. The process for conducting conventional clinical trials become difficult and risky at a time when the public is advised to shelter at home and healthcare facilities become overwhelmed with caring for […]
Protective Antibodies to COVID-19
April 1st, 2020 | Real World EvidenceWhether people develop immunity to COVID19 after being infected once is a pressing question. It’s of particular interest to several research developing plasma therapies, whereby antibody-containing blood plasma is extracted from recovered patients and administered to patients to help them fight off the infection. In rhesus macaques, a longitudinal tracking of re-exposure after the disappeared […]
COVID19 Infects the Nervous System
March 27th, 2020 | Real World EvidenceThe fact that COVID-19 patients have lost their sense of smell or taste is interesting because, if the virus infects the nose, it would use the exact same neurons as in the mouse studies to enter the brain. SARS‐CoV2 causes epidemic pneumonia characterized by acute respiratory distress. This novel coronavirus is similar to SARS‐CoV in […]
Clinical Studies: COVID-19 Gut Infection in Pediatrics
March 26th, 2020 | Real World EvidenceSeveral studies were conducted to evaluate the presence of COVID-19 in the GI track and eliminated with stools. The first case report in the USA of COVID-19 was published in The New England journal of medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2001191). The report showed, as early as day seven of clinical symptoms, elimination of COVID-19 in the stools of […]
Clinical Trial of COVID-19 Vaccine Begins
March 18th, 2020 | Real World EvidenceThe first participant in a clinical safety trial for a COVID-19 vaccine conducted by the Kaiser Permanente Washington Health Research Institute in Seattle was given an experimental dose on March 16, reports the Associated Press. Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna INC. Inovio […]