IDOT: Delivering standardized services and technology in an integrated manner

In pursuit of providing high quality and cost effective integrated solutions to the clients through its iDOT (integrate Data Operations & Technology), MakroCare has signed another contract to provide clinical data management, biostatistics services integrated with eClincial tools (mEDC, mIRT) from it’s Tech subsidiary DDi, for a Phase II study involving around 300 patients in US. With this contract, many more US investigational study sites will get opportunity to use simple, user-friendly but robust electronic data capture system (mEDC) and randomization tool (mIRT).

MakroCare’s integrated data operations & technology solution is a strategic approach towards delivering standardized services and technology in integrated manner to reduce costs for sponsors. This one stop integrated solution with study specific customized approach offers clients increased productivity, higher flexibility and lower oversight in cost-efficient manner.

What is iDOT?

MakroCare’s iDOT is a strategic approach towards delivering standardized services and technology in an integrated manner. Defining the right parameters / scope of the service and developing the right combination of ‘end to end process, teams and tools’ are the key activities that drive best value to customers.

Most of Pharma and Life sciences companies, currently have different vendors for data operations, technology and programming. Sometimes this works well as when selecting "best-of-the-breed" vendors who are a best-fit for that service or technology brings the best deliverables to clients. Unlike other services, Data Operations has matured over a period of few years and measuring the productivity and managing through metrics has become very manageable, if not easier. Clients should take advantage of this and consolidate vendors who can do multiple parts in data operations. This has obvious benefits and value as well. iDOT solution consists of best-in-class people, process and technology. MakroCare ‘s technology subsidiary -DDi has eclinical tools (mEDC, mIRT, mPORTAL) and solutions (ClinMetanoia, TULA), clients can leverage by paying only for the usage.

Services:

• Centralized project management
• Metrics driven data management
• Study setup programming aligned
• Standardized global SOPs
• Focused teams by TA & by Interventional/Observational

Technologies:

DDi, the technology subsidiary of MakroCare provides the products & technology for iDOT. DDi has built its technology competency with a unique blend of technical and domain expertise.

DDi Products

mEDC

mIRT

mPortal

DDi Solutions

Clinmetanoi(Analytics)

Tula(Risk & Compliance Management)

Advantages:

• Single sign-on interface for all tools
• Highly adoptable and scalable
• Fully compliant with FDA 21 CFR Part 11 and GAMP5
• Data hosted in USA (SSAE 16 Certified Data Centers)
• Reduced study demand variation risk
• Reduced technology risk

Why iDOT?

• Single vendor concept - common standards, higher accountability & easy to add/drop services & studies
• High ROI with lower cost, sponsor oversight time saving & less hand offs
• Smarter delivery models
• Quick implementation and 24x7 global supports
• No third party licensing and maintenance costs
• Global experienced teams
• Global client base
• ITIC Certified service management

MakroCare has an extensive experience and understanding of Clinical Investigation of Medical Devices and strong team of scientific, regulatory, clinical marketing and diagnostics who are spread across US, EU, Bric and Asean.