Case Studies

Case Study I
Turnaround Times Possible even at the tightest schedule
Given the relatively streamlined regulatory process for phase II projects in India, SPSOFT was recently presented a challenge by a pharmaceutical firm to coordinate and manage a full service phase II study involving multiple cohorts, a dose escalation regimen.

We were required to hold investigator meetings within 24 hours of subject completion in each cohort to allow seamless escalation to the following dosing cohort. This presented a particular challenge for the Data Management team given the <24 hour turnaround time available between last subject in each cohort and the subsequent meeting. A small biometrics team was quickly dedicated to this project, and a flexible workflow schema designed involving the research team at the site, SPSOFT data management and clinical monitoring teams, overseen by project management. Dedicated fax lines were put in place for transmission of CRF pages to SPSOFT DM as close to real time as possible upon completion of CRF data on site. Partnered monitoring staff was placed on a rotating on-call schedule to resolve any major queries with same-day turnaround, and live updates provided to client headquarters in site twice a day. The Data Management team was able to meet these tight turnaround times for each cohort in the protocol, and was on hand at each meeting to ensure database related questions could be clarified on the spot.

In the event, no database clarifications were required, the entire study progressed through full enrolment in less than four weeks with final study database lock occurring two weeks after the last cohort was dosed. The follow-up study to this milestone project was thus able to be started a full two months ahead of schedule.


Case Study II
When Real World Problems Real Solutions
Soon after starting a new phase II dose escalation study, SPSOFT Data Management team was notified by the Sponsor that the clinical site was unable to provide lab data exports in spite of earlier commitments due to technical issues at the clinic. The SPSOFT designed CRF was already in use with patients enrolling in the study, and there was no provision in it to capture lab data. Given the study was enrolling when this situation came to light, CRF redesign was not an option.

To deal with this scenario, SPSOFT Data Management quickly wrote a study specific SOP for the site, and provided training for manual entry of lab data under supervision into a commercial spreadsheet program. Upon transmission to SPSOFT, this data was then subjected to verification and 100% QC of all key fields, including crosschecks on all date and time points, out-of-range parameters and clinically significant results, assessed against AE/Med History entries in the CRF by partnered medical monitor. A 10% random spot check of all lab data in the final database was also completed with an error tolerance level of 0.05%, which passed comfortably.

This rapid shift in study procedures, helped by oversight provided by the SPSOFT Data Management team at site level ensured all lab data were provided on time, and database lock was met ahead of schedule without compromising data quality or making any amendment to the CRF or database.

Case Study III
Where Cost and Quality Meet with Compliance Obligations
Once a generic product is registered, it’s easy to assume no more clinical development work will be required.  Unfortunately, sometimes there is no choice.  A long standing client of SPSOFT approached the company with a situation where a drug was going to be sourced from new sites and there was to be a forced change in formulation.  Moreover, the client only had 10 months of guaranteed supply from the original source with the registered formulation.  To top it all off, the drug had three different strengths.

Working rapidly with the client’s logistics and regulatory teams, SPSOFT assigned a project team tasked with coming up with an overall program design that would allow it to run three concurrent studies, one for each strength of the drug, in a staggered approach at the same clinical facility.  Whilst this allowed a streamlining of site initiation and study team training processes and costs, it also meant the SPSOFT team and the site had to work extremely closely together to ensure each study was able to be run as an independent project with no possibility of a mix-up given three simultaneously run studies with the same drug.

In the event, through careful coordination and an innovative approach to study management processes, over 2,000 samples were collected across the three studies in a 10 week period and shipped off for laboratory analysis.

As drug assay results subsequently confirmed, the studies were conducted impeccably with no unpredictable outcomes.  Given the similarity of the studies, continuing with its approach of staggered but simultaneously run projects, SPSOFT data management and regulatory staff set to the task of pharmacokinetic modeling and analysis of all three studies as one.  This allowed a sizable streamlining of the workload involved resulting in crucial time savings for the client.

Ten months after being commissioned on this project, three completed studies were submitted to the regulatory authority confirming the new formulations of these marketed drugs.  The client was able to place a final order of the original formulation prior to its deadline to see it through the regulatory review process.  The new formulations were all subsequently approved with no interruption in supply.  A happy outcome all round!