It is an incredible offer to receive 75% savings, a team of 75 credentialed workers and an ISO certified environment to help in the management of your day to day clinical research requirements in today’s business environment. Many pharma/biotech colleagues from around the world who are engaged in the industry of making people healthy through medicine are taking advantage of such offerings. Max Neeman International, the clinical subsidiary of Max India, one of India’s largest healthcare conglomerates, is one such provider able to make such a claim of high quality work at very, very competitive rates. While India is currently working on checks and balances as they apply to conduct of clinical research in India, there are clear cut services unaffected. One service is Data Management and Biostatistics.
As anyone serving the clinical industry is aware, the Data Management Plan including Biostatistics is a key support structure that generates good data collection and reflection of the conduct of a research study. So when Max Neeman puts together a data management team for a client, there is a checklist containing tried and proven processes. The process typically begins with the protocol that builds out a plan that includes focus on an end product; i.e. a data management system that Max Neeman has 100% experience in successful implementation. The data management plan and database system developed allows for:
- Data structuring by SAS; it is a global brand, user-friendly application requiring as little as a half hour training
- Efficient analysis of data that is feasible and in accordance with an approved, effective and logical protocol, tweaked with agreement of sponsor
- Data base analysis and review
- Sample size calculations, CRF, patient diaries, table building
As data comes in it has to be reviewed and validated by a knowledgeable data manager from Max Neeman who has project-experience and as Max Neeman likes to say “has been in the trenches”. Basically, the data points need to be identified and validated against the objectives of the study.
The team you would typically find employed on a data management project headed by Max Neeman includes:
- Project Manager
- Database Design Expert
- Medical Writer
- Medical Coder
- Sponsor Rep
Challenges that data managers and clinical operations can experience include an example where recruitment may have started and then problems are noted with data collection. At this point, it can be very challenging to maneuver the study with limited disruption, but a good, experienced project manager will see the signals and quickly identify problem and solution that often results in a protocol amendment submitted to the IRB.
To avoid or limit any hiccups, communications is necessary – email communications, teleconference, face-to-face, PM Software-CTMS. The better the communications from step 1, the better the chances are that unexpected changes go down in numbers, but all the planning in the world is not 100% ironclad. You must have experienced project managers who see tell-tale signs of potential problems and who know how to move and react quickly.
So what does Max Neeman see as the most prevalent movement of change in the data management world? The answer has been and continues to be EDC for the next 5 years. There are pros and cons still today on the use of EDC but the next half decade should show paper left in the dust. One challenge of using EDC is when trials are conducted in rural areas with unreliable internet. Overall, this concern of rural inclusion in trials is being examined from a few different fronts.
When I asked Max Neeman whether people or technology make the difference in comparing a great engagement to an average data management project, the answer was not one. It takes both people and technology because technology brings rapid change and people are what it takes to raise concerns. With an experienced team of data management professionals you get an excellent result.
As you embark on selecting your next data management vendor, be sure to look at qualifications for:
- 21 CFR compliant-security for the data
- Global standards; guidelines are compliant with GCP
- SOPS are aligned to regulatory standards
- Team is highly trained and credentialed data experts
- Controls and processes are in place
- System and document validations are in place
Key reason Max Neeman International is a top contender for data management projects:
- Focus is on Quality
- Excellent Service at Competitive Pricing
- Committed to Project Planning following the 80/20 rule. Good project planning up front allows for effective implementation!