BA Launches Clinical Data Management Services

BA Research Clinical data Management (CDM) team comprises of Clinical data Coordinator, Data Managers, Data reviewers, Medical Coders and Clinical Programmers with significant experience in CDM Process and Solution.

 

The team comprises of Life science and Technical personal with working experience at ICON, Accenture, Quintiles, and Lambda.The team is extensively trained in the 21 CFR Part 11, CDISC, ICH GCP guidelines.

 

We have invested in SAS PheedIT (3.1.0 Version) that has Hybrid capability to run Paper and EDC studies. We also use industry standard coding tool MedDRA, WHODD and Frame maker for CRF designing.

 

Our services include: CRF Designing, Data Base Build and programming, Data Entry, Discrepancy Management, Medical Coding, External Data Reconciliation, Quality review, Study Set up, Study Conduct and Study Close out

 

Mrs. Arpana Prasad, our Chief  Method Development Officer attends Bioanalytical workshop at Montreal, Canada

Attending 3rd workshop on recent issues in regulated bioanalysis was a great experience learning the views of industry & regulatory members. This workshop provided the opportunity to meet members of different regulatory as well as representatives of various pharmaceutical companies. The brainstorming sessions provided valuable inputs for providing conclusions on the discussion topics and consensus points  - Mrs. Arpana Prasad.

 

The topics discussed in the workshop were 1) incurred sample reanalysis, 2) Hemolysis testing, 3) Variable injection volumes, 4) investigating acceptable results, 5) manual modification of chromatograms 6) latest bioanalytical techniques, 7) World wide ACN shortage, 8) Metabolite testing 8) Anticoagulant counter ions, 8) OTC testing, 9) Blood stability testing

 

The presentations were made by speakers from US food & drug administration, UK MHRA, Health Canada TPD & various pharmaceutical companies'. The topics were presented by Dr. Brian P. Booth (USFDA), Louise Mawer (U.K.MHRA), Eric Ormsby (Health Canada TPD), Douglas M. Fast (Pfizer), Dr. Fabio Garofolo (Algorithme pharma), . Patrick T. Vallano (Mylan Pharma ceuticals), Dr. Rupinder Phull (Barr Laboratories), Xia yen (Appotex), Dr Mario L. Rocci (Prevalere Life Sciences, Dr. Stephen Lowes (Advion Bioservices), Dr. Robert Masse (Anapharm).

 

BA Research has recently added state of art instrument API 5500 LC/MS/MS system in the bioanalytical lab.

This system gives higher level of speed & five times increase in sensitivity with highest quantitative accuracy and lower limits of detection compared to other Triple quadrupole instruments. This instrument would help in developing methods on molecules like nasal sprays, hormones or steroids which requires very low limit of detection.

 

Medicines Control Council of South Africa

We had a successful audit by MCC of South Africa at our Ahmedabad facility.

Suppository Study

BA Research India has conducted first suppository study in healthy human subjects. Along with mode of administration of Investigational product, the protocol had other specific criteria which made the study more challenging. Healthy male subjects were recruited within the timelines and study was executed meticulously with the help of trained, experienced staff and advice of our on board consultants. Complete protocol compliance was ensured and study completed within the timeframe ensuring 100% subject compliance.

Our MD/MV group has developed new methods

·         Atorvastatin with metabolites

·         Mesalamine

·         Dexlansoprazole

·         Norethindrone

·         Drospirenone

·         Promethazine

·         Flunarizine

·         Rizatriptan

·         Glipizide

·         Sirolimus

·         Lidocaine