Data Management
Clean, high-quality data is one of the most critical elements of any clinical trial. Therefore, Data management is a core service of Excel Life Sciences and a critical part of our overall customer value proposition. Between the full-time dedicated clinical research coordinator we place at the site and our highly skilled project and data management personnel; we ensure that the data coming out of the investigative sites for your study is the highest quality possible. We have the experience, bandwidth and technology necessary for on-time database lock for any study that we take on and the commitment to make it happen.
Our Data Management team is headed by Dr. Lilly Sanathanan one of the leading experts in the field of Data Management and Biometrics. She has had extensive pharmaceutical industry experience including leadership roles at Abbott Laboratories, CIBA-GEIGY and SmithKline Beecham and was the Director of Research and Methodology Planning Staff at the Center for Drug Evaluation and Research, and the US Food and Drug Administration.
ELS offers the following data management services:
- Case Report Form (CRF) Design and
- Production
- Database Design and Validation
- Data Entry Screens
- Remote Data Entry (RDE)
- CRF Log and Tracking
- CRF Review
- Double Data Entry and Verification
- Programming and Validation of Edits for Consistency Checks
- Clinical Data Review
- Query Generation and Resolution
- Correction Processing
- Audit Trail Generation
- Adverse Event and Concomitant
- Medication Coding
- Data Quality Reviews
- Database Lock and Archiving
- Database Status Updates
Sample Data Management Experience:
| Therapeutic Area |
Number of Trials |
Number of Subjects |
| Dermatology |
1 |
224 |
| Endocrinology |
4 |
521 |
| Gastroenterology |
2 |
1,200 |
| HIV/Infectious Diseases |
5 |
1,550 |
| Neuropsychiatry |
1 |
120 |
| Obstetrics |
1 |
466 |
| Oncology |
2 |
180 |
| Respiratory |
6 |
1,250 |
| Total |
22 |
5,511 |
|