Here is a snapshot of some of the key areas of QED’s experience:
Case Study 1: Large Oncology Programme
A mid-sized European biopharmaceutical company approached QED with a large oncology programme. This consisted of 1 phase II/III and 2 phase IIb prostate cancer studies. In total, 528 patients were involved across 76 sites in 15 countries (including the Nordic region, Central Eastern Europe and South Africa). For this comprehensive and challenging programme the sponsor needed a global monitoring solution and regulatory support in all countries involved, whilst avoiding large global CRO overheads. Consequently they chose QED.
Case Study 2: Complex Obstetrics / Gynaecology Project
We successfully delivered a complex phase II study in the area of obstetrics and gynaecology. A major biopharmaceutical company was looking for a vendor who could handle a highly specialised and complex trial investigating Assisted Reproductive Technologies. They chose QED. This was a multicentre study needing to recruit 200 patients, across 7 sites. QED was able to draw on its substantial clinical team to identify specific individuals with direct or relevant experience to work on this study. Our successful completion of this study has resulted in QED being awarded subsequent projects in additional therapy areas, illustrating the diverse but comprehensive experience we can share directly via our team members rather than just at a company level.
Case Study 3: Early Phase Preferred Provider
QED was selected to work strategically with a major global pharmaceutical company and provide a pool of CRAs to work across all phase I and small number of site studies. We quickly identified suitable personnel and built a team for this sponsor. The team members all met or exceeded the sponsor’s requirements in terms of experience and were effectively trained in the sponsor SOPs and practices. Our ability to rapidly meet the specific resource requirements of the sponsor, through the flexibility and scalability of our model has ensured the successful roll out of multiple early phase projects in short succession. The experience gained from this early phase preferred provider relationship has led to provision of support for numerous phase I studies for other top 5 pharmaceutical sponsors.
Case Study 4: Rescue Projects
QED successfully transitioned a large phase IIB, long term safety study for the treatment of patients with prostate cancer, for a major European biopharmaceutical company. The study involved over 20 sites in multiple countries (including Nordic Region, Central Eastern Europe & Russia). This was a complex study and the sponsor had become dissatisfied with their service provider. They wanted a European monitoring solution whilst avoiding continental/global CRO overheads so they chose to transition the project to QED. QED took on the study which had already been running for more than a year and which had seen multiple changes made to the CRA team by the previous vendor. Some sites had experienced as many as 4 changes to their CRA, within a year. This was obviously having an adverse impact on Investigator relationships, quality and consistency.
QED assumed responsibility for this challenging study and immediately installed back-up CRAs for each individual CRA, so that in any unforeseen circumstances the study was in no danger at any time. The QED CRAs successfully cleared a large backlog but also worked to reassure and get disillusioned and sceptic Investigators back on side. At the time of the end of QED’s involvement (approx. 2 years) we had guaranteed absolute minimal staff turnover and superior standards of quality in delivery of the study, demonstrating our aptitude with rescue studies.
QED have subsequently worked on a further 3 “rescue” projects for similarly disillusioned sponsors, in the past 2 years alone.
Case Study 5: Full Service
A Biotech company was looking to identify a suitable CRO to manage their phase II study looking at biomarkers of inflammation. The sponsor was looking for a full service solution with their chosen CRO taking responsibility for Project Management through to Final Clinical Study Report, including identification of third party vendors, such as Labs and Drug Supply partners. QED was selected based on its complete full service offering, flexibility in contracting and cost effective solution. QED worked closely with the sponsor to identify an appropriate Clinical Study Manager and tailored their involvement to suit the needs of the project, with a flexible FTE allocation reflective of the study workload. This ensured that the Clinical Study Manager assignment truly added value to the study and was not just another layer of unnecessary project managment. The study is in the process of being initiated and the Sponsor is very satisfied with QED’s performance to date.
Case Study 6: Registry Survey
A large global Pharmaceutical company approached QED from a Key Opinion Leader recommendation, to assist them with a specialist late phase project. The Medical Affairs group of the Sponsor wanted to conduct a Registry Survey on patients with Atrial Fibrillation. QED were selected to run this project and proceeded to identify sites across the UK. Working closely with Investigators and Site staff QED’s intimate knowledge of working in the UK and particularly on specialist projects enabled us to rapidly start-up this time-critical project.
Case Study 7: Global Haematology Study
QED was selected for a highly complex haematology study being conducted in patients with Idiopathic Thrombocytopenic Purpura (ITP). To add to the complexity of this project, the study was transitioned from another CRO due to recruitment issues. QED immediately conducted a comprehensive and thorough feasibility in record time and based on this came up with a recruitment plan to address these issues. This involved rapidly expanding the scope of the project to include additional sites and countries. Our flexibility allowed us to scale up operations to meet these needs whilst our local expertise on the ground in each country in the form of investigator / site and regulatory experience and relationships helped us to accurately assess and implement suitable corrective action.