For digital transformation of CROs, it would involve seamless operations of clinical trials (BA-BE and Clinical trials) and
Maintaining enterprise-wide quality in all aspects is much essential. Especially QC and QA departments with their predefined operational norms play an important role in this managing enterprise-wide quality. Quality processes such as Change Control, Market Complaint, Deviation, Investigation, Risk Assessment, OOS, OOT, etc. can be digitised for much efficient functioning. Along with, Document control – controlled and uncontrolled copy – authoring, review, publish, distribution (for SOPs, Specifications, Work Instructions, any other documents). Also, along with eLearning and Training with ready availability of training material, Employee dossier with their training details and much more…
CROs offering pharmacovigilance services to pharma companies; when the drug is in the market and any side effect – adverse events (mild to severe to death) would be captured and the information processed as mandate and, also, submitted to the regulatory body, may decide the fate of that drug. Pharmacovigilance and Medical enquiry for adverse events and submission of such information is defined as drug safety.
CTM – is a multi-functional platform which allows a CRO (Contract Research Organization) in planning, managing, designing, executing, monitoring and analyzing trial related activities and data in adherence to the protocol obligations and regulatory requirements. An end-to-end solution suite which cater to all the needs of clinical research project starting from Project Management, feasibility assessment, volunteer or patient enrolment using iris recognition technology, capture clinical trial data, multi-level review process, data compilation to data archiving. This includes solution package for Early phase trials, Late phase trials, Oncology trials, Registry trials, Past approval trials, Bioanalytical automation – for various different types of study trials.
Trial Master file for each trial; It essentially is digital capturing, managing, sharing and storing those essential documents and content from clinical trials. eTMF enables complete sponsor and investigator site files to be rapidly created for each study and helps to ensure readiness for audits and inspections.
Electronic signatures of CSV documents, workflow driven signature captures, other documents with/without workflow – track the signature process – even store and archive documents (older and current) for convenience, audit readiness.
