Case Study # 1: Unique Therapeutic Expertise in CNS:
CliniRx is currently working on a phase II CNS study, being conducted in Europe and India. This Study involves a very complicated patient diary as the primary efficacy parameter. Sponsor’s prior experience with such diaries had been full of challenges, and it was expected that due to inconsistency in the diary entries, the sample size would definitely increase. An increase in sample size leads to project delays and increases the costs and overheads.

Realizing this, CliniRx developed a unique model of helping the sites in training the patients (for diary completion). Additionally, CliniRx developed a central review mechanism of the patient diaries. Each of the 900 patient diaries across more than 50 sites in India and Europe were reviewed by Medical Experts within CliniRx. The gaps were PROACTIVELY identified and plugged.

As a result, against all expectations, the interim analysis found the diary entries to be adequate and sample size re-estimation did not lead to increase in subject numbers. This was made possible by the UNIQUE therapeutic expertise within CliniRx that ensured a robust process to ensure a high quality of output.

Case Study # 2: ‘Lead CRO Role’ for a multinational study:
CliniRx has recently completed a study where it performed the following services for a European Client for study conducted in India and Europe:

• Protocol Review & Customization

• ICD Customization; Translation and back translation

• Regulatory review of CTA followed by its approval in India

• GLOBAL project management (Sites in India and Europe)

• Vendor selection and management (central lab; central ECG; IVRS; drug packaging & distribution; PI meetings; CRF printing etc.)

• Data Management (Included writing the DMP; Database designing; CRF printing; Edit Checks; Medical Coding; DCF generation and resolution; database lock)

• Safety management (Including CIOMS Generation & Communication; ESN; SUSAR; DDL; ADO management Causality Assessment; Review of data listings etc.)

• Study Monitoring

• Medical Monitoring

• Statistical Analysis and writing the final ‘Clinical Study Report’

Case Study # 3: Quality Management
CliniRx was contracted by a US client for a phase II study, using Electronic Data Capture. The study was ongoing at over 20 sites in India; Singapore & Hong Kong; and was being managed by another CRO. Sponsors’ independent QA raised quality concerns; CliniRx was brought in at this stage. CliniRx PAUSED the project for 2 weeks; All the sites were evaluated through a quick tour by Senior CRAs & CliniRx QA team.

In consultation with the sponsor, a quality plan; co-monitoring plan and a medical monitoring plan was put together by CliniRx. First, the sites were retrained, then all the CRAs in the monitoring team were trained by CliniRx. Finally, 75% of the sites were re-initiated. These sites were able to meet the enrolment target, while maintaining the ‘Quality & Integrity’ of the study. The trial got a ‘thumbs up’ from the sponsor

Case Study # 4: Timeline Management
CliniRx concluded a phase II trial for a European Client. The study involved very tight timelines, and was conducted at sites in India and Europe. CliniRx was the lead CRO responsible for global project management; the European CRO was working on CliniRx SOPs. FOUR weeks after the FPI, CliniRx project manager detected very slow enrollment at European sites. CliniRx Project Manager studied and identified the gaps. He concluded that the European CRO would not be able to meet the enrollment goal within the given timelines. He proactively contacted the sponsor, shared his analysis, and got their approval for enrolling additional patients in India. He then submitted an application to Indian Regulatory Authorities for enrolling additional patients in India. Within 30 DAYS, CliniRx team enrolled its own share, PLUS 30% more patients to compensate for the European shortfall. All of this was made possible by a proactive PM, who worked closely with an enthusiastic team.