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Data, Freedom of Information releases and corporate reports
How to join the phase I accreditation scheme.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Points to consider when using real-world data in clinical studies
Detailed information on the sources, quality and scope of the UK Clinical Research Delivery programme key performance indicators.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How investigators and sponsors should manage clinical trials during COVID-19
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The pre-clinical evaluation team at VDEC provides a safe and controlled environment to test new vaccines and therapeutics before they progress to clinical trials
VDEC responds strategically to AMR pathogens and new emerging threats (fungi, viruses, and bacteria), by determining the most appropriate research goals to combat these pathogens
Deficiencies in Omega’s pharmacovigilance system are not thought to affect the safety of the products that they market.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
Actions that trial sponsors should consider to build resilience into clinical trial design
VDEC works with global leaders from all sectors to develop and deliver the vaccine and therapeutic products we need to protect us from infectious diseases.
We use decades of experience in safe bioagent handling to support partners in research, development and testing of vaccines and therapeutics
Guidance for healthcare professionals on providing free prescriptions for participants in the HEAL-COVID or STIMULATE-ICP long COVID clinical trials.
UKHSA offers a unique opportunity to harness world-class intellectual, scientific, and operational expertise for public health solutions.
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