Medical Affairs and Clinical Research
The Strategic Clinical Innovation Organization method, developed by BBCR, can help streamline the clinical trial process by operating on the fundamental principle that strategy and design are keys for the success of drug and medical device development.
March 29th, 2022 | Medical Affairs and Clinical ResearchBiologics can provide opportunity for identifying a treatment or cure in cases of rare disease. BBCR team experience in biologics for rare diseases included rare cancers and precision medicine can help develop a targeted strategy including studies with fewer patients that control for safety issues.
March 23rd, 2022 | Medical Affairs and Clinical Research
BBCR team experience in biologics for rare diseases included rare cancers and precision medicine can help develop a targeted strategy including studies with fewer patients that control for safety issues. Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan […]
BBCR partners with small and medium sized drug and device biotechnology firms. Our clients are clinical researchers and innovators looking for an efficient path to approval, and come to us from across the globe. Reach out today to learn more.
March 16th, 2022 | Medical Affairs and Clinical Research
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Who We Serve: Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulartory strategy consultancy in need of preparing a pre-IND meeting […]
The SCIO concept is the value proposition solution for cost-effectiveness and risk management in clinical development. Learn more about how BBCR can help.
March 9th, 2022 | Medical Affairs and Clinical Research
Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop a clinical and regulatory roadmap consisting of simplified clinical programs, streamlined protocols, and cost-effective trials.
February 22nd, 2022 | Medical Affairs and Clinical Research
Our Boston-based, integrated, boutique consulting team specializes in rare disease and orphan indications, and is dedicated to supporting pharmaceutical innovators and nurturing each product’s strengths. The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process.
BBCR’s experience and understanding of how the FDA views orphan applications and structuring a development program to deliver the data and rationale to satisfy the FDA can substantially reduce the review period and increase approval.
February 16th, 2022 | Medical Affairs and Clinical Research
A strategic approach creates opportunity for time efficiencies The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases and precision medicine impacting disease sub-populations. BBCR’s team of experts can help your company create a roadmap specially customized to ensure successful product […]
BBCR uses innovative approaches to de-risk your product development. For our clients interested in Proof of Mechanism and Proof of Concept – PoM and PoC – BBCR has the expertise to ensure successful product development at any stage of development.
February 2nd, 2022 | Medical Affairs and Clinical Research
The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target […]
Trial for Duchenne muscular dystrophy cell therapy.
January 27th, 2022 | Medical Affairs and Clinical Research
Duchenne Muscular Dystrophy is the most common fatal genetic disorder to affect children around the world. The first patient, a six year old boy, received, in November 2021, an infusion of DT-DEC01, a novel cell therapy containing Dystrophin Expressing Chimeric Cells (DEC), in Phase I pilot clinical study for the treatment of Duchenne muscular dystrophy (DMD). […]
BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies.
January 25th, 2022 | Medical Affairs and Clinical Research
BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target site of action Investigate […]
BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. We invite to reach out to learn more.
December 29th, 2021 | Medical Affairs and Clinical Research
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. We understand that navigating the rare disease development process requires expert guidance. BBCR can assist in the following areas: Biologics Biosimilars Small Molecules Medical Devices Drug Repurposing Why the SCIO? Clinical trials are […]