K.E.M Hospital, Pune celebrated its diamond jubilee in 1972. At that time a need was felt to further improve and expand their services.Read Further
KEM Hospital is a multispecialty 550 bed public hospital, providing advanced diagnostic and therapeutic services in all major indications, and easily approachable by the patients from the main city and periphery, this results in a good amount of patient pool.
KEM Hospital provides clinical research services for pharmaceutical and biotechnology product development from Phase I to Phase IV. Clinical trials must be scientifically conducted using appropriate methods on the basis of strict observance of Good Clinical Practice and ethical considerations. A separate dedicated clinical research facility compliments the work of the investigators by providing them vital administrative and infrastructural support.
KEM Hospital has a advantage of having an efficient PI group in all major therapeutic areas like Oncology, Diabetology, Pediatrics, Cardiology, Nephrology etc.
We are glad to have studies running under Dr. Minish Jain (Oncologist)
At KEMHRC, our Oncology unit has been providing clinical research services for pharmaceutical product development since 2007.
Our full time staff of Study Co-ordinators ensure that planning and execution of the clinical trials is smoothly managed from start to finish.
Clinical Research Facility:
Oncology Research Unit has well experienced and efficient Principle Investigator , Sub- Investigator team & Research staff having an Oncologist, Haematologist, ICU Intensivist, Oncosurgeon, Project Manager, Medicos, CRCs, Nursing staff etc.
Dedicated space for clinical trials:
KEM Hospital Clinical Research Department has a dedicated space within the hospital premises exclusively for conducting clinical trials. This includes OPD rooms for Consultants to see patients, Research Room, Procedure room, Laminar air flow for Chemo preparation , Drug storage , Patient's ward (Day Care Centre).
Site SOP : Site has it's own site SOP for studies being carried out in the Oncology Unit.
A separate fully automated temperature controlled drug storage area for storage of the investigational product is available.
We provide laboratory services for those sponsors who are interested in local labs instead of central labs.
PROJECT DETAILS OF DR.MINISH JAIN
1. Study Title: "Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera® in patients with Non-Hodgkin's Lymphoma"
2. Study Title: "Prospective, multi-centre, randomized, open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-016/HerceptineR(HerclonTM) when given intravenously in patients with metastatic HER2-overexpressing breast cancer
3. Study Title: "Prospective , multi-centre, randomized, open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-023/ AvastinTM intravenously in patients with metastatic colorectal cancer"
4. Study Title: A randomized, multiple-dose, multicenter, comparative parallel study to evaluate the efficacy, safety and pharmacokinetic characteristics of intravenous infusion of Rituximab (Hetero) and reference medicinal product (Rituximab, Roche) in Indian patients of Non-Hodgkin's Lymphoma (HERILY Study)
5. Study Title: An open label, randomized phase III trial of BIBW 2992 and Vinorelbine versus Trastuzumab And Vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior Trastuzumab treatment"
6. L00070 IN 305 B0 "Study Title: A phase III study of Vinflunine plus Capecitabine versus Capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an Anthracycline and who are Taxane resistant"
7. A multicentre , randomized, open label ,two-period, two-treatment, two-way crossover, single dose bioequivalence study comparing Temozolomide capsules 250mg (manufactured by Fresenius Kabi Oncology Limited, India) to the reference listed drug Temodal (Temozolomide) capsules 250mg ( manufactured by SP Europe ) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting conditions.
8. Efficacy and safety of Paclitaxel nano-dispersion concentrate for injection (PICN) in subjects with metastatic breast cancer: A randomized, open label, active controlled, comparative, parallel group, and multi-centric study.
9. Protocol title: "A phase 1 pharmacokinetic, safety, and tolerability study of Paclitaxel injection concentrate for nano-dispersion (PICN) administered once a week in subject with advanced solid malignancies in Indian population."
10. Protocol title: "A safety, tolerability, pharmacokinetic, and efficacy study of Docetaxel injection concentrate for nano-dispersion (DICN) in subjects with unresectable locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).