Dia Landing Page

  • May 2020
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@ DIA

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MAKROCARE We welcome you to visit our booth #

@ DIA, please ask for

What to expect @ DIA Launch of new service

Private label services. A data management system that you can brand without upfront investment. You can use world class infrastructure with Oracle Clinical, EDC, SAS and a dedicated call center for resolving queries Page 1

June 21 - 25

Backed by Intelligent Technology Makrocare’s services is backed by Intelligent Technology which is custom made for every client

Pluggable solutions Each of our solutions are standardized as per CDISC, EHR, 21 CFR part 11 compliance. The advantage being each of the report or data is compatible with any standard thus allowing interoperability Page 2

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Patient recruitment On demand from our clients in US and Europe we are in a process of launching online Patient recruitment portal in India. This service will coincide with Indian r e g u l a t o r y authorities pending decision for allowing Phase I trials i India Page 3

Makrocare would like to introduce hardware to purchase or staff to Makrocare will provide all the this unique service for Phase I manage. units,

CROs

training to your staff online or in

and

small A system and dedicated staff to person. It is our responsibility to pharmaceutical and biotech support your data management integrate our data with the existing companies who wish to leverage needs. CRFs,to make personalized data our proprietary platforms in order to provide comprehensive data

Studies built in industry standard

portal for your customers.

will sign a Oracle Clinical, Electronic Data Makrocare management services under their Capture (Data Management Confidentiality agreement that it own name. This would be done by Systems), IVRS, SAS , Biostatistics will not contact your customer Makrocare’s Private Label Program which we are delivering to our top without you instruct us to. and provides: Clients. We encourage you to learn more A data management system that Additional value-added service for about this service at DIA and get a you can brand without: up front your clients and a new revenue quote in 24 hours. investments, ongoing licensing and stream for you; service fees, software to install, Makrocare @ DIA

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We base our quotes on the value which we add to client’s operations. We are always in the forefront as far as testing new technologies as Stem Cells, Nano technology, Personalized medicine is concerned. We understand the culture, community of each country, based on which our operation strategy is decided. Enabling Intelligent Technology sponsors to commercialize the maturity stage and avoiding off We share electronic data between Sponsor teams in Drug Discovery, Pre-clinical and Clinical development for them to take real time decisions. As we have partnered with Oracle for its Clinical Data Management System we are all set for conducting Adaptive trials for reducing the failure rate and cutting costs for the sponsors.

product , to conduct market research for first - in - class drug or for setting up price for the product, product positioning , reimbursement , dealing with HMOS, marketing campaigns et.al

We at Makrocare analyze the study and advise sponsor for Typical Product development Life cycle repositioning of the drug in case of trial failure. We help Pharma/ label marketing and inviting Biotech companies to study the FDA’s ire. secondary indication during the We have established very good first trial itself. This helps them in relationship with the investigators repositioning the drug after the which would be beneficial for the

Pluggable solutions At Makrocare all our reports are standardized as per the latest standards , CDISC, 21 CFR Part 11, compliant with most standard Electronic Health Records for interoperability. This enables you to just plug our solution within

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your existing infrastructure without any need of customizing.

We do this by first studying the existing IT infrastructure of the client, legacy data, Standard Operating procedures, Regulatory affairs of the country, state the trials are conducted in.

Makrocare @ DIA

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Makrocare’s Online Recruitment portal

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Patient

Please ask us about this new feature

Indian regulatory authorities will Patient metrics (Including its Customizing patient literature be allowing Phase I trials in India genetic profile for Personalized depending upon the regional for the drug discovered in US, EU medicine) language & Japan Investigator & Patient rating Weeding out non performing sites within 4 weeks of Helping Pharma and patients commencement of trial Makrocare is gearing up for this by enabling compassionate use scenario by building a portal for Advising Sponsors on # of Allowing real time changes in Online patient recruitment which available patients meeting the protocols for measuring outcomes will go live before end of this year. inclusion/exclusion criteria per site Following up with the patients till the trial gets over to avoid drop Portal will contain the below data: outs Makrocare @ DIA 3

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