Qualified & highly experience
Bioequivalence service desk that work as your local expert

Monitor Biostudy - BioVigil

 

What is Biovigil

Biostudy monitoring service delivered by experts.

The industry has witnessed a number of cases where numbers of biostudies were rejected by authorities due to data integrity issues during CRO audit. Since then USFDA and EMEA have become more vigilant especially with Indian CRO and regulatory audits have also become more stringent. As a procedural part, USFDA and EMEA have also started asking "Biostudy Monitoring Report" performed by a qualified person from sponsor or independent competent authority. Performing clinical and bioanalytical monitoring is a special task and need skills and subject understanding to assure that study is in complete compliance.   Biostudy Monitoring does not mean being present at site but is about ensuring GCP / GLP processes are being followed by the CRO and study is compliant.   Pharmadesk has track record and experience of handling more than 400 biostudies with various complexities and guarantees that study will never deviate from quality aspect to avoid rejection of the biostudy.

Solution

Solution

You have developed the product and have handed it over to a CRO for the most important activity, the BE study. It is like extending your prized asset to an outsider. As you may not have the expertise to analyse what is being done with the product, you need a process on whom you can trust completely. Through Biovigil, Pharmadesk has developed a system which provides answers to all the challenges related to BE study monitoring.   We have carefully designed check lists for Monitoring   Our monitors witness all activities and ensure that those are carried out with strict adherence to protocols and within the boundaries of regulatory environment. Because we understand even a small mistake may lead to rejection of the study.

Biovigil Features

Biovigil

Provides solution to following challenges

Business Challenges
Challenges 1

We need qualified & experience team to monitor our bioequivalence studies.

Other Challenges

Compare Services

Services Bio vigil On track Augment Synonym
PRE STUDY
Product Feasibility
Site identification & Qualification      
Regulatory approval/BE NOC & T License      
CLINICAL PHASE
Product Feasibility    
Sample Size estimation or Approval  
Statistical Design or Approval  
CRF, ICF, ECG, CSR Review    
Study Monitoring & Study Compliance    
Study Monitoring observations & reporting    
BIOANALYTICAL PHASE
MD MV & Analytical data Review    
STATISTICAL PHASE
Statistical & PK report review & Data Interpretation    
Root cause analysis    
TRACKING OF PROJECT
TRACKING OF PROJECT      
REGULATORY
Scientific Advisory Meeting    
Biowaiver & other Regulatory Query Response    
Controlled Correspondence with Regulatory Authority