Preclinical / Nonclinical
Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans.
Biopharmaceuticals
Clinical Development
Introduction
Helping to navigate the complexity of biopharmaceutical clinical trials
Formally reviewed and approved clinical trials are used to determine the safety and efficacy of candidate molecules in volunteers and patients and form a key part of the clinical development strategy. For biopharmaceuticals, it’s not easily possible to use other techniques and methods in place of clinical trials to compare existing treatments, or to assess treatments in a new or different population group.
Typically consisting of five phases — three during development and two post-marketing — clinical trial studies can be difficult to plan, implement, and manage. This is in part due to the variable nature of biological products and vaccines which require specialist skills and experiences to ensure study design and end pints are clinically and commercially viable.
At Woodley BioReg, our team of experienced clinical consultants help our clients in achieving product licensure by using their practical industry and clinical experience to ensure regulatory expectations are addressed. We’ll engaged subject matter experts, clinicians, statisticians, and epidemiologists to ensure robust and focussed clinical plans and protocols are developed.
To find out more about how we support clinical trials, visit our resource centre
Designing Clinical
Protocols
Our strategically designed clinical trials protocols are written with product licensure in mind smooth the path to bringing your biological products to market. We ensure clinical studies are suitably powered with sensible clinical endpoints, which is particularly important in ensuring a consistent and coherent clinical development pathway.
Writing
protocols
Our expert team — typically comprised of clinicians and medical writers with extensive experience in the preparation of biopharmaceutical documents — can write detailed and comprehensive protocols that can be rapidly reviewed, approved and executed.
Our clients customarily provide us with key inputs such as purpose, target population, scope, limitations, inclusion / exclusion criteria, and primary and secondary endpoints, and we will draft clinical protocols for review, refinement and approval.
Determining statistical
Significance
The point at which a biologic is considered to be safe and effective for its intended use can often be difficult to determine, particularly given the natural, intrinsic variability in the molecules. Our consultants work closely with our clinical statisticians to guide and advise on powering studies with sufficient subjects to demonstrate statistical significance in clinical benefit.
Applications for
clinical trials
Clinical trials applications differ globally with regard to the information required for review in the EU and US, there are further subtle difference for biopharmaceutical products. We’ll support and guide you throughout this process and provide strategic advice when we’re preparing and submitting your application — including agency meetings, such as Scientific Advice and Pre-IND meetings.
Find out more about the different types of applications depending on your location, visit our resource centre
Developing, implementing,
and managing the clinical programme
Understanding the regulator’s expectations from clinical studies is our driver in ensuring studies are designed to meet both the applicant / sponsor and regulatory requirements. We do this by applying our knowledge of the legislation and experience in clinical indications and treatment regimes. We facilitate study centre compliance ensuring the smooth delivery of clinical trials and the timely collation and interpretation of clinical data.
Regulatory
strategy
We recognise and encourage the continued refinement of regulatory strategies as data is generated and to ensure ongoing regulatory alignment. Our consultants will advise you on the regulatory process at all stages, including the most opportune times to engage with the regulators and address or remove potential road blocks, and consider potential accelerated and rolling review pathways.
