What Is A Clinical Supply Agreement
“This agreement with Oxford Biomedica means that together we can continue the development of AXO-Lenti-PD in the case of Parkinson`s disease,” said Pavan Cheruvu, Chief Executive Officer of Axovant. “We are pleased to expand our partnership with Oxford Biomedica, the world`s leading lentivinal vectors, as we are able to expand production of AXO-Lenti-PD to support our Phase 2 and Phase 3 clinical trials and enable the product to be commercialized. This is another reciprocal achievement for our Parkinson`s program, where we expect to include the first subject in a randomized, apparently controlled study in 2021. A particular area of clinical procurement, which may require special attention, is the clinical care stability test. Sometimes the sponsors of the study know exactly what is needed, and sometimes they need help to create an appropriate stability protocol for their clinical care. One way or another, stability test requirements must be taken into account at an early stage of project planning. It is always a good idea to have the help of a stability manager in that direction. There are several areas that need to be analyzed and addressed that may ultimately have a significant impact on the timing of studies and on the ability to generate an effective protocol that meets the requirements of the clinical trial. This is not limited to the availability of validated methods, the transfer of methods, the establishment of stability protocols, the duration of stability tests, stability and third-party testing. Ultimately, specific discussions on stability at the beginning of the project planning cycle could significantly reduce the time it takes for stocks to be released to clinical sites. Facilitating a quality audit If the compatibility between the client and the contractor is recognized, the small obstacle of a quality audit must always be overcome. Preparing for an exam is not an easy task. However, an effective way to ensure the success of the audit is for the contractor to often review its own systems either with internal resources or with external consultants.
Twice a year, self-assessment is a proven method, as it will highlight weaknesses or areas of improvement. As soon as a research sponsor agrees to examine a contractor, an effective practice for the contractor in the preparation of an audit is to ask the audit team of the study sponsor for an agenda. An action program will help the contractor`s organization by preparing all relevant documents in advance to ensure that the audit is carried out smoothly. In addition, the agenda should be forwarded for consideration to all heads of department of the contractor. A final warning, a day or two before the exam, to all employees who confirm the client`s audit visit is also a good practice. Finally, quality audits will be the determining factor in the awarding of the contract by the master of study to the contractor; Therefore, additional care and effective communication within the contractor organization are essential to the success of the review. A contractor`s project manager should ensure that an experienced quality assurance manager assists with the audit.