There are two schools of thoughts regarding the data management and statistical business Mithas Practice.
The first school of thought proclaims that unless Mithas Labs has well established software like Oracle
Clinical or Clintrial, the data management system can not be 21 CFR Part 11 compliant. And since
many global CROs and pharmaceutical companies have already used to this system and software,
unless, we use the comparable system, we will not be able to compete with them. Hence, it is absolutely a must to invest in Oracle Clinical or some such validated software in order to obtain global data management business. The second school of thought believes that the data management system can be compliant with 21 CFR Part 11 even without those validated software. We believe that a data management package well developed using Oracle 9i for database management (back-end operations) and Visual Basic or VB .net or JAVA or VC++ or some such software for front end for programming and interphase design, will give the desired output. Mithas Labs utilize the skill-sets of Indian IT talents and develop create a tailor-made clinical trial package for data entry and analysis. Mithas ensure complete documentation of database preparation, installation of the software, trial runs, training, security checks, etc. to confirm compliance.
Another model Mithas would like to establish, is the retained Full Time Equivalent (FTE) Model. In this model, the pharma companies outsource the job of developing the facility, offices and human resources (FTEs) [Statistical Programmer, Statistician, Data Viewer, DB Designer and Medical Writer] to a Mithas, who could be a CRO or an IT company with the understanding of the clinical trial data management and biostatistics business. The pharma companies provide hardware, software and arrange for their installation and training. This model is essentially an extension to the contract staffing model as the service provider provides the office and manpower both. This model promises the vendor to act as a Functional Service Provider (FSP) on project/protocol basis after certain pre-decided years. This model demands a lot of initial investment and provides an opportunity for Mithas to learn tricks of the data management business besides promising a lot of future core business as an outsourcing partner.