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Case Studies

These clinical trial management case studies will help you learn from the success of others as well as provide you with industry knowledge. Please click on the case study you wish to read below to learn more.

Pharmacovigilance (PV) plays an important role for patient safety through the collection, recording, analysis, monitoring and prevention of adverse effects with drugs and therapies. This extends to collecting and collating solicited and unsolicited reports of suspected adverse reactions associated with both investigational and marketed medicinal products for human use. One method of documenting these events is the Individual Case Safety Report (ICSR), which is "an individual report of suspected adverse reactions in relation to a medicinal product that occur in a single patient at a specific point of time."1

A small biopharmaceutical company that focuses on therapeutics in immune disorders was developing an oral therapy to treat relapsing multiple sclerosis. During the development of this therapy an off-target effect of bradycardia occurring up to 6 hours after the dose was identified. To meet regulatory requirements for phase 2/3 trials to evaluate efficacy and safety of the drug, heart rate (HR) needed to be monitored via ECG by a centralized lab for a minimum of 6 hours after the dose. After HR normalized at the 6-hour timepoint the patient could be discharged from the neurology clinic.

A medical device company has a long-standing relati onship with Bioclinica (>10 years, 380+ studies total) and wanted to increase their data quality while decreasing the monitoring ti me required during their clinical trials. The sponsor is currently an avid user of the Bioclinica EDC and CTMS systems as well as Bioclinica Data Manage-ment services. However, they wanted to decrease the associated ti me and errors by directly populati ng the EDC with their assessment data rather than writi ng the source data on paper for later transcripti on into the EDC.

A multinational specialty pharmaceutical company was using another vendor for pharmacovigilance (PV) services. Due to ongoing quality issues, poor communication and poor project governance with their current vendor, the company approached Bioclinica for PV services, including aggregate reporting, focusing specifically on PADERs.

A specialty pharmaceutical company focusing on the areas of pain management and addiction medicine decided to outsource their PV support due to growing demands on their limited resources and lack of in-house PV database.

A global pharmaceutical company with headquarters in Japan was using the services of another vendor to submit cases that occurred in Japan (domestic) and cases that occurred outside of Japan (foreign cases) to the PMDA. The company explored several options. Due to Bioclinca’s strong pharmacovigilance expertise and high quality, the company decided to partner with Bioclinica for their end-to-end case processing needs.

Conducting clinical trials for rare, debilitating diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while not typical, might help to reach these patient populations who otherwise would struggle to participate in and comply with clinical trials. However, implementation of this strategy is challenging because of many reasons such as the logistical considerations and regulatory requirements regarding patient confidentiality and quality control.

Read our case study and learn how Bioclinica collaborated with a sponsor to successfully ship study drugs directly to patients.

Having grown to a premier research organization with 400 clinical trials to its credit, HCRI's clinical trial management needs had surpassed the conventional processes it had been using to manage and monitor information and documents related to its clinical studies. The Institute's 140 users relied on Excel spreadsheets and other manual processes that proved labor-intensive, inefficient, and a barrier to team communication.

Read our case study and learn how Bioclinica's OnPoint CTMS creates a centralized environment and provides a highly efficient way to manage clinical trials and streamline clinical operations.

Before engaging with Bioclinica, this CRO used a manual process to calculate payments for almost all of their studies. This admin-intensive process was resource-intensive, slow and error-prone, and the CRO knew they needed an automated system that could provide accurate payments in a much timelier fashion.

Read our case study and learn how Bioclinica has helped this CRO to become fully self-service and seamlessly make payments to sites around the world in a timelier, more accurate, efficient manner.

Given that attaining sites has become increasingly competitive globally, this sponsor recognized that with their large studies (and the large number of sites required to perform those studies), it was crucial to keep their sites satisfied by paying them accurately and on time.

Read our case study and learn how Bioclinica was able to fully integrate all of the trial sites into their system.

Bioclinica understands the pain points of both sponsors and sites when it comes to the financial management of clinical trials. ClinPay and ClinViz are two examples of technology solutions within the Bioclinica suite of Financial Lifecycle Solutions (FLS); the former automates the financial management of clinical trials by initiating timely and accurate payments based on Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) data, as well as transparency for the sponsor regarding the payments sent and requested, and the latter is the payee (site) portal that provides sites with real-time access to their complete history. Essentially, payments from the sponsor are initiated, recorded and tracked in ClinPay, and sites have access to all of the payment details through ClinViz.

Read our case study and learn how Bioclinica's ClinViz, when partnered with ClinPay, provides a unified site payment portal solution. We will discuss how a sponsor recently transitioned from a manual payment process to the use of ClinPay for site payments.

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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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