Qualifying Thirty Party
CRO
Technical Data Analysis
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.
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.
Pharmadesk expert visits the site and check for the preparedness & readiness of site. All the documents are verified such as:
The regulatory authorities demand the study to be conducted with the recommended parameters and processes. Although everyone is aware of this fact very few have the capacity to follow the same. One of the most important factors that we take care of is the complete evaluation of the capability of the CRO on the quality front. Pharmadesk expert visits the site and verify the site is compliant with GCP and GLP requirements.
Our regulatory affairs team supports you in regulatory concerns, approvals and relevant documentation during pre-study and post-study submissions which includes the following:
How to tackle Data Integrity issue of a CRO ?
How to Qualify CRO for BE studies?
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Our business development team will contact you and arrange telecon.
