About Us
13396
page-template,page-template-full_width,page-template-full_width-php,page,page-id-13396,bridge-core-1.0.4,ajax_fade,page_not_loaded,,qode-content-sidebar-responsive,qode-child-theme-ver-1.0.0,qode-theme-ver-18.0.9,qode-theme-bridge,qode_header_in_grid,bridge-child,wpb-js-composer js-comp-ver-5.7,vc_responsive
 

About Us

About MIC

As Clinical Research continues to evolve, so has the role and importance of the Clinical Expert.

Med Indite Communication (MIC) is an oncology-focused Medical Research Organization, incorporated in 2016 to provide a higher level of scientific engagement, medical expertise, and value to clients through leadership, deep domain knowledge, and a scientific focus approach. MIC works closely with biotech/pharma clients to build scientifically robust concepts/processes to achieve a better outcome, increase operational efficiencies, and ensure consistent regulatory compliance.

 

MIC is well positioned to offer clinical development consultancy mainly in Medical Monitoring, Clinical Translation, Strategy and Development, Clinical-Regulatory, and Due Diligence activity in the oncology domain. The team has worked on >20 phase I to IV studies/projects in hematologic malignancies and solid tumors and is well-versed in the different tumor evaluation criteria such as RECIST, CHESON, irRC, iRECIST and Olsen and applicable guidelines such as NCCN, ASCO, ESMO, and PCWG3. The team members have in-depth knowledge and hands-on experience with targeted therapies including New Chemical Entities with different mechanisms of action (e.g., PI3k/AKT/mTOR inhibitors, CRAC channel, IDO/DHO-DH inhibitors, MNK inhibitors, TRK inhibitors), immune-oncology (IO) drugs (pembrolizumab, atezolizumab), and vaccines (e.g., H1N1 vaccines, SARS-COV-2 vaccines, meningococcal meningitis, rabies, measles).

 

MIC team is constantly focusing on Medical Monitoring, Clinical Translation, Strategy and Development, Clinical-Regulatory, and Due Diligence activity with innovative ways and finding solutions for our clients to carve out a niche for themselves in these services. MIC also helps in conceptualizing clinical study designs, planning, and exploring innovative approaches/ PK/PD models for proof-of-concept studies of New Chemical Entities (NCE) and New Biological Entities (NBEs) and interaction with the Indian regulatory authority DCGI/Subject Expert Committee (SEC), Pre-IND meeting, End of Phase 2 meeting (EOP2) and various research funding agencies (DBT/BIRAC) at different stages of drug development.

 

In the last few years, MIC team members were part of multiple key milestones that includes submission of EOP2 to the USFDA, IND submission, protocol development, CSR development, and medical monitoring of the studies in the US and Europe for solid tumors and hematological malignancies, and due diligence activities.

From The Statistical Analysis

100+

Statistical analyses

15+

Clinical Study Protocols

10+

Clinical Study

25+

Manuscripts

15+

Publications

30+

Conference Posters/abstracts

 OUR SERVICES

Med Indite communications offers an extensive list of services to accommodate your research needs.