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Clinical Research Newsletter

  • Patients heartbroken after failure of Alzheimer’s clinical trials
    Biogen and Eisai were running a clinical trial for Alzheimer’s disorder. They lost billion dollars after the failure of this trial. Mind and memory of an individual in Alzheimer gets deteriorated to an extent where they are not able to perform their function. Four drugs related to Alzheimer’s disorder were approved by FDA. However, all of them were just helping systems, none of them is slowing or reversing the disease.
    New Inclusion Policy in Clinical Research: Effective way to include all Ages
    Newer challenges related with recruitment planning and study design will be set to the industries involved in clinical trials with the expansion of inclusion policy.
    Shorter regimen supported by clinical trials for multidrug-resistant TB
    A non-inferiority phase 3 trials has been done in 424 subjects having rifampin-resistant tuberculosis and are susceptible to aminoglycosides and fluoroquinolones. Random selection of subjects was done to impart either a long regimen of 20 months or short regimen of 9-11 months in line with WHO guidelines. It was concluded from the trial that short regimen was alike the long regimen in safety terms.
    A more focused trial for pancreatic cancer
    The study at University of Glasgow was initiated with the purpose to match more effective and targeted treatment with patients. University of Glasgow’s clinical trials project along with a research program by Precision-Panc had initiated the trial to bring a patient-specific pancreatic cancer treatment approach. Cancer Research UK has given the major funding for the project. The project has recently recruited 100th patient for their study which is a remarkable success.
    Phase 1 Clinical Trial initiated for APVO210
    A novel Bi-specific antibody, APVO210 developed by Aptevo Therapeutics has been developed to treat Inflammatory and Autoimmune disorders. As per the officials of the firm, the Phase 1 clinical trials for the bi-specific antibody have been initiated. The major aim of the biotechnology company, Aptevo Therapeutics Inc. is to develop novel hematology, autoimmune and oncology therapeutics.
    Draft Guideline of Bioavailability Trials by FDA
    There will be guideline update by FDA regarding how to conduct trails by clinical investigators. The update will be done to in line the approval standards with updated science and technology. As per the FDA official, they will also update the review process at each stage of innovative products.
    Upcoming of Rare cancers
    The number of common cancer types is reducing and an increase in uncommon cancer type is observed in the study conducted at National Cancer Center Hospital, Japan.
    Reports of fragmentary Clinical hold on MGD009 Phase 1 study by Macrogenics (MGNX)
    Macrogenics, Inc. is a biopharmaceutical company at the clinical stage, it is targeting for discovering and developing a monoclonal antibody-based therapeutic system for cancer treatment. This organization made an announcement on December 6th stipulating that they have received a letter from USFDA in which they have put some kind of restriction on Mono-therapy study of MGD009 Phase 1, which is a B7-H3 x CD3 bispecific DART ® molecule along with MGD009 and MGA012 (anti-PD-1) combination study.
    Draft Guidance Released by USFDA to conduct FIH clinical trials for Cancer Drug Developers
    A draft guidance to conduct first in human (FIH) clinical trials for cancer drugs has been released by USFDA which will help sponsors in designing clinical trials to speed up the development of cancer drugs through multiple expansion cohort study designs.
    Domagrozumab (PF-06252616) clinical studies evaluating the treatment of Duchenne Muscular Dystrophy terminated by Pfizer
    A Phase 2 safety and efficacy study (B5161002) and an open label extension study (B5161004) evaluating Domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy has been terminated by Pfizer. Duchenne muscular dystrophy (DMD) is a rare, serious, debilitating childhood genetic disease characterized by progressive muscle degeneration and weakness and significantly shortened life expectancy.
    Pilot Program for encouraging the complex trial designs for Drugs and Biologics launched by USFDA
    USFDA has launched a pilot program to support the use of complex innovative trial designs in the development of drugs and biologics. The launch of pilot program was decided after discussion held during a public meeting held in March although certain concerns were raised by stakeholders such as Genetech and Biogen regarding flexibility and scope of such trials.
    FDA granted Orphan Drug Designation to ASLAN003 for acute myeloid leukemia (AML) treatment
    Orphan Drug Designation has been granted to ASLAN003 which is a product of ASLAN Pharmaceuticals by USFDA for the treatment of acute myeloid leukemia (AML). ASLAN003 is an orally active potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which depletes the intracellular pool of pyrimidines thereby lowering the levels of adenosine triphosphate and induction of the tumor suppressor p53 which at high levels can trigger apoptosis (programmed cell death).
    TrialAssure has joined hands with Otsuka Pharmaceuticals to provide its Clinical Trial Disclosure Reporting System
    TrialAssure is a global clinical trial disclosure and transparency reporting company which helps clients to meet regulatory compliance goals through a flexible, scalable and streamlined platform that gets regularly updated with respect to ever-changing clinical trial disclosure requirements. Otsuka Pharmaceutical Development and commercialization, Inc. is a global healthcare company based in Tokyo, Japan.