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.
Pharmaceutical
Clinical Development
Introduction
Helping to navigate the complexity of pharmaceutical clinical trials
Formally reviewed and approved clinical trials are used to determine the safety and efficacy of a candidate drug in volunteers and patients and form a key part of the clinical development strategy. Where it’s not easily possible using other techniques and methods, clinical trials can be used 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. At Woodley BioReg, our team of experienced clinical consultants help to ease this process and support our clients in achieving product licensure by using their practical industry and clinical experience to ensure regulatory expectations are addressed. We engage 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
We strategically design clinical trials and write protocols with product licensure in mind — smoothing the path to bringing your pharmaceutical product to market. We ensure clinical studies are suitably powered with sensible clinical endpoints — particularly important in ensuring a consistent and coherent clinical development pathway.
Writing
protocols
Our expert team — usually comprised of pharmaceutical clinicians and medical writers — can create detailed and comprehensive protocols that can be rapidly reviewed, approved and executed. Our clients typically 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 drug is considered to be safe and effective for its intended use can often be difficult to determine. 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 trial applications differ globally with regard to the information required for review in the EU and US. We’ll support you through data collation, and provide strategic advice when 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, via 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 creating a rapid and smooth route to market.
Regulatory
strategy
We recognise and encourage 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 / remove potential road blocks, and consider potential accelerated and rolling review pathways.
