The Drug Development Office is in a unique position to offer an excellent partnership opportunity for academic researchers and the pharmaceutical industry. Our project management and regulatory teams, our UK-wide clinical reach, and our manufacturing sites provide an unparalleled integrated clinical trials capability.
The Drug Development Office's manufacturing facilities consist of the Biotherapeutic Development Unit at Clare Hall Laboratories in Hertfordshire and the Cancer Research UK Formulation Unit at the University of Strathclyde, Glasgow. Clinical trials need a reliable and high quality supply of the new therapies that are being tested. These manufacturing facilities ensure that all stages of drug development projects are properly supported, and all manufacture complies with EU good manufacturing practice (GMP) guidelines.
Links with ECMC Network
Our historic and close relationship with Experimental Cancer Medicine Centres means we have unique access to research clinics throughout the United Kingdom.
Project Management and Sponsorship
The Drug Development Office manages and sponsors phase I/II trials through all project stages. Through our integrated capabilities in project management, pre-clinical development, clinical operations and regulatory affairs, we offer academic institutions and companies a powerful mechanism for developing new medicines, diagnostics and prevention therapies and taking them into man for the first time.
For our researchers, this means a continual commitment and single point of contact from early stages of protocol design through to final trial report and archiving.
Studies use Phase Forward InFormGTM electronic data capture to collect, manage, clean and review clinical data.
The Data Management group comprises of Data Managers and Database Programmers who design the eCRF in Phase Forward InFormGTM electronic data capture. Data are checked for completeness and consistency and we work closely with colleagues in Clinical Operations, Medical Sciences and Pharmacovigilance to ensure that high quality data is reported. We also program SAS® data listings and tables to facilitate data review and report writing.
Quality and Regulatory
The DDO conducts and manage clinical trials to the highest quality standards and in compliance with regulatory and pharmaceutical Good Practice (GxP) standards. This encompasses Good Clinical Practice (GCP) including Good laboratory practice (GCLP) and Good Manufacturing Practice (GMP).
In order to achieve this, DDO operates a Quality Management System (QMS) which comprises inter-related and interacting policies, standard operating procedures and resources. The Quality Assurance function also carries out an annual programme of audits on laboratories, systems and selected clinical trials, all of which go towards assuring the highest standards of quality in DDO trials.
To fulfil our obligations as clinical trial sponsors, the DDO offers a full pharmacovigilance (PV) function. The PV team utilises the Aris Global ARISg database for collecting and assessing Serious Adverse Events (SAEs) and identifying reports which require regulatory reporting. We also carry out ongoing monitoring and evaluation of safety on all our clinical trials is conjunction with our Medical Sciences Team and our Protocol Safety & Review Board (PSRB).
Clinical Partnerships team
Dedicated to sourcing projects and enabling contractual arrangements with researchers and industry partners. Please contact us (firstname.lastname@example.org) for further information and advice on project applications.