The first step is to identify the most effective regulatory pathway based on your product and chosen indication. We will identify the major market countries where approval will be beneficial to your marketing or licensing strategy. We will identify any expedite programs or regulatory incentives that may apply and carve out the best regulatory pathway based on your product’s stage of development and current funding.
Archives: FAQs
Document Tracking & Review
We establish virtual data rooms and tracking systems for the numerous project-associated controlled documents – including analytical protocols, reports, SOPs, specifications, certificates of analysis, tech transfer reports, master batch records for engineering and GMP runs, and stability protocols and reports. We also provide critical quality input and expert reviews into these documents as needed.
Project Management
B4D has the experience to manage issues that inevitably arise along the way. We work with chemistry, manufacturing and analytical experts and quality consultants to oversee work conducted at CMOs. Our team provides cross-functional project management support using online collaboration tools for timelines and virtual meetings to keep on top of action items and minimize delays.
Supplier Qualification
Initial supplier qualification can be based on self-assessments by the CMOs but we ensure that Quality agreements are established and site audits are performed prior to GMP manufacture.
Identifying & Selecting CMOs
Finding the right manufacturing contract manufacturing organization (CMO) for the project is key. The process starts with obtaining proposals from the most suitable CMOs based on experience and reputation – pricing is not the only consideration.
Estabilishing Quality Systems
Early stage companies may not have the QA systems in place needed to meet GMP requirements. We work with you to develop a complete set of SOPs tailored to your company to ensure regulatory compliance as the project moves forward.
Clinical Reports & Publication
In addition to protocol writing, at the completion of the clinical trial and following the analysis of the data, B4D can produce the Final Study Report and also assist in the writing and submission of publications to targeted journals based on the study results.
Execution of FIH Study
Following regulatory approval, B4D can assist in all or select aspects of clinical operations to ensure the conduct of the clinical study adheres to the principles of Good Clinical Practice (GCP). B4D can identify qualified vendors through an RFP process and ensure the CRO selected is the best qualified for the study. Having previously worked in the therapeutic area, B4D can identify clinical trial sites through our network and work with the CRO on management of the sites throughout the conduct of the study. B4D also has preferred data management groups for all aspects of statistical analysis and data collection and management of clinical trial information. We also work with pharmacovigilance groups for the management and reporting of SAEs that may arise during the study. Throughout the process, B4D will use online management tools to ensure development milestones are met so that costly delays are not incurred at this vital stage of the product development process.
First-in-Human Clinical Study
In designing the first study B4D will consider both the competitive and regulatory landscape and include not only evaluations of safety and dose-finding but endpoints which provide proof of concept for target engagement. This provides the necessary information for determining the design and sample size of subsequent studies as well as support fundraising efforts. B4D will assemble a Clinical Advisory Board (CAB) consisting of clinical experts in the indicated therapeutic area to develop this novel FIH protocol. B4D will refine the protocol by engaging regulatory authorities in Pre-IND/CTA meetings prior to filing the IND/CTA.
Planning Nonclinical Studies
Based on the type of product and the selected indication, B4D will work with toxicology experts with the required experience to develop a nonclinical program of studies to support the FIH clinical trial. Where possible, study elements will be combined to maximize the information obtained from a single study. B4D will identify qualified CROs to conduct these studies under GLP and can organize audits of the selected facilities. B4D will also map out the nonclinical requirements at each stage of clinical development to ensure you are prepared for each step in your regulatory filing without incurring large financial commitments in the early stages of clinical development.
