Clinical Trials Case Studies

Case Study #1

A European biotechnological company outsourced its clinical development programme[SC1] to 3 CROs to handle the study at sites in Europe and US, became aware to the fact that half of the programme budget has been already paid to the CROs, although the patient recruitment was around 10%.

The company asked TransCom’s advisers to propose a model that will allow them to successfully complete the study within the allocated budget.

Following several meetings with the client and CRO’s representatives, and a thorough review of the contracts and study plans, TransCom’s advisers designed a new study plan and new agreements between the client and the CRO, achieving the following:

Increase efficiency on working processes, and significantly decrease the expected timelines left to end of study
Cost-effective management model, €1 Million savings
New agreements with the 3 CROs ensuring completion of study within budget

Case Study #2

An international pharmaceutical company outsourced a multicenter, regional oncology clinical study. The study was initially planned to be conducted at 15 sites, with an expected recruitment of 200 patients. The client requested a Senior CRA on full FTE to handle all aspects of the study.
Working according to the TransCom’s cost-effective resourcing model, the Project Manager proposed to assign a Senior CRA on 0.10 FTE, a CRA on 70% FTE and a Site Coordinator on 50% FTE that will be allocated to work at the clinical sites and support the site staff in recruiting patients and performing administrative tasks.
Due to TransCom’s cost-effective resourcing model, the client obtained a fast and efficient teamwork, and 25% savings on direct service costs, that allowed an additional year for follow-up of the patients.

Case Study #3

An Israeli pharmaceutical company that was planning to conduct a multicenter, international clinical trial in US and Europe, was examining several proposals from different CROs that were higher than the allocated budget by the company.

TransCom’s advisers studied the proposals, the client’s internal resources and their experience in clinical trials management.

TransCom’s advisers designed new working plans combining the client internal staff and CRO’s staff, achieving the following:

Significant clinical trials budget (approx. $3 Million)
Client’s positioning for increased fund raising opportunities

Case Study #4

An international pharmaceutical company was planning to conduct a local clinical trial jointly with a health service provider in Israel. The allocated budget for the project was not enough for contracting all the services that the health service provider requested from a CRO
TransCom’s advisers studied the budget, the health service provider’s requests and proposed to combine TransComand the client’s internal resources in order to enable the company to manage the clinical study to the highest standards and within the budget.

Case Study #5

A pharmaceutical company was planning to perform a clinical study on a rare indication with very low incidence in the population. The company addressed a number of senior professionals working at 15 hospitals in several countries, to get an estimate on recruitment capabilities and timelines.

TransCom’s advisers investigated the case, and assisted in building an infrastructure for cooperation between the senior professionals at hospitals and professionals from community clinics, to achieve the following:

The study was performed at 5 sites instead of 15
Patient recruitment target was achieved in 6 months instead of 1 year.

Rescue Cases

TransCom’s advisory team was contracted to review clinical study documents, a few months after the recruitment of patients for the study was started. TransCom’s advisors found that the study CRF was missing a field for collection of an important parameter that is needed for the primary endpoint analysis. Therefore, the client could not use the data collected from the patients that were already included in the study. The mistake was corrected before additional patients were included in the study.
TransCom’s advisory team was contracted to review a clinical study protocol upon submission to the FDA. TransCom’s advisors found that the parameter needed for the main objective analysis is not suitable for the patient population (only 10% of the patients population could achieve this value). The primary endpoint of the study was changed to a more suitable parameter, and the study was successful
TransCom’s advisory team was contracted to audit a clinical site at which contradictory results were obtained. For a Phase II clinical study. The investigators reported that the treatment was successful, but the data gathered from this site pointed to the conclusion that the treatment failed. TransCom’s advisors found that due to a wrong translation of the study documents, the answers provided by the patients to Quality of Life questionnaires were misinterpreted. The documents were translated, corrected and validated by TransCom. The patients were asked to answer the newly translated questionnaires, and the outcome analysis proved to be coherent with the physicians’ clinical impressions. The company then progressed in its clinical development programme to phase III clinical studies.

Learn more about performing clinical trials with TransCom: