Case Studies of Success
Successful interventions by us through
rescue studies.
Clinical trial in oncology (solid tumour): 20% more patients in half the time envisaged
- Selected investigators didn't meet target after week 19 (internal deadline).
- Immediately recruited centres were able to beat target.
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Clinical trial in oncology (haematology): trial brought to a successful end (within time and budget) after bankruptcy of previous CRO.
- Adding two countries in CEE resulted in higher than expected recruitment, beating timelines and accommodating a higher patient number due to higher than expected screening failures.
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Clinical trial in renal transplant: trial brought to a successful end (within time and budget) after bankruptcy of previous CRO.
- US-made trial protocol was not adapted to European particulars. Amendment allowed typical concomitant treatment; additional incentives for investigators resulted in rocket-like recruitment rate.
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Clinical trial in hypertension: remaining recruitment in half the time envisaged, after ‘clarifying’ issues of inclusion criteria.
- Imbalance through a few centres rapidly recruiting in one country (quickly reaching their prefixed upper limit) had to be counteracted by opening centres in one additional country.
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Clinical trial in women's health: required timelines met after shifting into CEE
- Centres did not enrol according to their estimates after first feasibility. Newly recruited centres with different characteristics which were more appropriate for the study indication helped to meet the target.
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Clinical trial in hypercholesterolemia: UK based sponsor’s first study in India. High screen failures in the study which was unexpected and slow subject recruitment.
- Pre-screening potential subjects
- Addition of 2 more sites
- Conducted camps
- Vigorous follow-up
- EA manpower dispatched to sites.
Sponsor’s remark on completion of target recruitment achievement:
“Personally, I greatly appreciate all the diligence and dedication from all of you to meet this important milestone in our company’s first ever clinical trial in India.” |
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| Clinical trial in asthma: a Phase II study in 44 patients had to be recruited from 2 sites within 3 months through speedy recruitment, quality of data, and quick turnaround time on query resolution. |
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