Often, the preparation of an IND application and the planning of a Study Protocol can be aided by some early advice from the FDA, in the form of a pre-IND consultation.
Biological Resources Inc assists in identifying any outstanding questions which would benefit from an audience with the FDA. Biological Resources Inc works with the client to assemble the pre-IND package and by participating in the meetings with the Regulatory Agency, as required.
The FDA has specified a format that the IND application should follow. Templates and support for determining what content should be included in an IND package are available from Biological Resources Inc.
Areas where additional support and resources would be beneficial include preparation of the informed consent document and creating a Data Safety Monitoring Plan (DSMP).
As the study progresses, the Regulatory Sponsor is responsible for seeing that the study is conducted according to the current approved protocol. Changes to the protocol can be made by submitting amendments to the FDA, and Biological Resources Inc can assist. This FDA amendment is in addition to any related IRB requirements.
Even if no protocol changes are made, regulations require that reports be submitted to the FDA on an annual basis, at a minimum. Biological Resources Inc will assist with both reminding Regulatory Sponsors about reporting milestones and also in the preparation of the reports.
Serious Adverse Event reporting is also critical to the continued operation of any clinical trial and Biological Resources Inc will assist researchers/clients in abiding by the proper reporting procedures. There are several categories of adverse events and they have varying timelines for submission of the reports, based on severity.
The FDA has created the Expanded Access Program which allows a qualified physician to provide an investigational drug or device to a patient outside of a clinical trial. There are certain criteria which must be met for this Expanded Access use, and coordination with the company providing the therapeutic is critical.
If you have a patient who would benefit from the use of an investigational product that is not currently approved, and there is no clinical trial available for this patient, Expanded Access program is the best way out.
Biological Resources Inc provides guidance on completion of the required FDA forms and navigation of the entire process.
When it comes to clinical staffing support, Biological Resources Inc has a strong track record of supporting successful trials.
For pharmaceutical, biotechnology, and medical device firms, we support our client’s clinical workforce strategy with talent exactly when and where it is needed. Throughout, our goals are the same as our clients:
Because we understand the unique workflows, processes, timelines, and standards unique to each clinical phase, you benefit from properly vetted candidates. Clinical staffing support areas include:
From key contributors to outsourced teams, we offer contract and permanent recruiting across all phases, therapeutic areas, skill sets, and geographies. If it has anything to do with clinical environment, it’s a job we can fill – from hands-on scientists and technicians to IT specialists and everything in between.
Most of our clients choose a direct sourcing model, but we also partner with contract research organizations (CROs), functional service providers (FSPs), managed staffing providers (MSPs), and specialized outsourced providers. How you engage is up to you – we’re always ready to go.
Clinical study protocols are the foundation of clinical trials. A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol also outlines steps for protecting subjects and obtaining quality data.
In order to ensure compliance with subject protection standards and statutory requirements, protocols are submitted to both an Institutional Review Board (IRB) and to regulatory authorities (e.g., U.S. FDA) for rigorous review prior to a Sponsor being allowed to conduct a study. Poorly designed or poorly written protocols can have the following negative consequences (among others):
· The IRB or regulatory authority requires protocol rewrites and updates.
· Clinical study site staff misinterpret aspects of the protocol, compromising conclusions or data integrity.
· The results do not support conclusions needed to move forward with drug development.
· The study gets put on clinical hold, where the Sponsor cannot run the study (or at least certain aspects of it) until all issues are resolved.
These consequences are costly and delay timelines. In the worst-case scenarios, poorly written protocols can jeopardize patient safety or result in data that do not support regulatory approval. To decrease these risks, the following best practices can help create clear, well-written protocols that are operationally feasible, generate quality data, and are compliant with regulatory guidelines.
The primary question is where the clinical trials are going to be conducted. All studies must be compliant with International Conference on Harmonization (ICH) guidelines and have subject protection that is founded in the Declaration of Helsinki, but the laws and required regulations of the country.
For example, studies conducted in India, under the purview of the CDSCO, must also be compliant with applicable sections of the New Drugs and Clinical Trail Rules (2019); however, these requirements would not apply at an international site, like US. In another example, studies conducted in Europe would need to follow new GDPR (General Data Protection Regulation) mandates, while studies run in non-adopting countries would not.
Because of the many country- and region-specific requirements that exist, it is crucial to identify where the study will be conducted before writing the protocol. This will ensure efficiency and prevent costly delays and rewrites later.
Develop the Synopsis and Schedule of Events Early in the Process:
The protocol synopsis is an overview/summary of the protocol. The schedule of events is a tabular description of all study-related events and assessments, including: subject screening and enrollment, safety assessments, efficacy evaluations, pharmacokinetics sampling, etc.
These sections offer the perfect opportunity to solidify the study design with all stakeholders, including sampling/assessment timepoints, before the full protocol is drafted. Finalizing a synopsis and schedule of assessments prior to authoring the full body of the protocol can eliminate inconsistencies within the text and prevent confusion or deviations that might require a protocol amendment.
Provide Clear Objectives and Associated Endpoints - Since all drugs present some level of risk, all clinical studies should have clearly defined objectives that seek to answer important questions. In addition, every objective should have an endpoint or endpoints that will provide the necessary information without confounding or ambiguity.
Writing clear, definitive objectives for the study will allow the Sponsor, regulatory authorities, and the IRB to critically evaluate if the proposed study design is likely to provide the intended information. It can also help the Sponsor as they begin to think about possible outcomes and how the study design will support not only the conclusions from this particular study, but the development program as a whole.
Services
· Collection of specific sample types by consultation with Biorepository personnel.
· Search of Biorepository databases for specimens meeting research project needs.
· Retrieval and distribution of de-identified/coded banked specimens.
· Guidance on long term storage and inventory management using
Biological Resources Inc Biologicals ensures best in class Clinical Data Management services to enable effective study design, conduct, discrepancy management, close-out and regulatory compliance.
Clinical trials are adaptive and spread across multiple sites, making data integrity integral to the success of your trial. Efficient collecting, transferring, and managing of data during a clinical trial is critical for the smooth functioning of the drug development process.
The data from clinical trials is extensive and it needs to be collected appropriately, streamlined, analyzed and presented in formats that are in accordance with regulatory compliance standards. With our expertise, we can deliver you greater efficiencies in terms of time, effort and cost, while ensuring the highest quality outcomes for your clinical trial. Our expert medical writing team includes physicians who have an in-depth knowledge about various therapeutic areas and will support your medical writing services from phase I to phase III and beyond to post authorization studies.
At Biological Resources Inc Biologicals, we have the right technology to support your data management needs. We deliver full clinical data services across CDM, Biostatistics, Statistical programming and Medical Writing through a flexible, scalable and global delivery model.
We understand your need for our teams to be onsite, offshore, near shore or a combination. We can cater to it depending on your short- and long-term objectives.
The stringent regulations on safety monitoring and their periodical revision have led to increased safety data collection, analysis and regulatory surveillance, and increased costs. Thus, Pharmacovigilance has become a critical phase in clinical development programs.
Our Pharmacovigilance Services help you ensure regulatory compliance, enhance efficiency and reduce costs significantly. We are offering the service of CRO in US that operate within a partnership model, where you benefit from our domain knowledge, quality systems approach, multi-disciplinary safety expertise and adherence to reporting timelines of the EMEA, FDA, MHRA and other competent authorities. We, at Biological Resources Inc, offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.
Biological Resources Inc Biologicals is one of the Pharmacovigilance companies in the US is offering comprehensive solutions across all phases of clinical development and post-marketing to pharmaceutical, biotechnology and medical device companies. The complete range of high-quality services offered by the Pharmacovigilance team encompasses:
Drug safety and Pharmacovigilance Services:
· Set up and maintenance of global safety database.
· Literature search in compliance with regulatory requirements.
· Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs.
· Online coding (MedDRA, WHO DDE) of Adverse Events.
· Medical review of case reports.
· Preparation of safety narratives.
· Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities.
· Preparation and submission of expedited reports to regulatory authorities.
· Short lead-in times, clear and concise processes tailor made to meet client expectations