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

Qualifying Thirty Party CRO
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What is Endorse

Scouting the perfect CRO for your BE study through a magnifying glass.

Over the years, multiple CROs have been catering to the requirements of BE studies for generic industry. CRO generates a large volume of data at different stages of the project. It is very challenging or almost practically unfeasible to perform 100% review and verification of the generated data.   Ensuring integrity of the clinical trial data generated for regulatory submissions is a major challenge today for sponsors. Appropriate CRO selection is the first step towards increasing chances of a successful outcome. There is a need of mapping your requirements and CRO capabilities to check the perfect fit. Probably you need to check on this on a case by case basis. Although compliance, cost, experience, quality and time to deliver are important parameters, these are not really sufficient. A 360-degree approach for evaluation is required to avoid unwanted surprises in future.   Here Pharmadesk can help you out.

Solution

Solution

Your aim is to find a scientific and subject expert and not merely another vendor, so when it comes to deciding on the right CRO for your BE study you need a systematic approach and well-defined selection criteria which can filter the available options to choose a ‘Perfect One’.   With years of experience in the industry we have developed a strong network with most of the recognized CROs in India and abroad. After supporting almost 400 BE studies for various dosage forms at multiple CROs, we have complete understanding of the current landscape in the BE CRO industry. With this background we are the solution you need to find a suitable CRO for your BE study.   We have worked with almost every CRO in some or the other capacity. We know the key decision makers and internal processes of individual CROs as we are in regular touch. We enjoy special slots and rate contracts with a number of recognized CROs. This provides us a perfect edge to support you in scouting the perfect CRO for your BE study.

Endorse Features

Endorse

Provides solution to following challenges

Business Challenges
Challenges 1

How to tackle Data Integrity issue of a CRO ?

Challenges 2

How to Qualify CRO for BE studies?

Other Challenges

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Services Endorse Final Review
Site qualification & approval  
GCP and GLP site audit & compliance  
Review of CSR, ICF, CRF eCTD & ECG, Review.  
Review of study protocol & sample size  
MD & MV Review  
Analytical report review  
Clinical & bioanalytical data review  
Statistical & PK report review  
Failed biostudy interpretation  
Development strategy analysis  
Pre formulation study analysis