Bestat is familiar with the regulatory framework and international standards. By evaluating the current development phase, data and reports, our experts strategize the actionable and potential solutions to customer not only in communication with the regulatory bodies, but also in proceeding to next step.

On-site or remote (in-house) monitoring to verify data collected, assess site compliance with applicable regulations, international guidelines, IRB or EC requirements and SOPs, follow-up with study recruitment status, and provide assistance where needed.

We offer cost-effective, time-saving, and high-quality solutions to collect and verify data based on customer’s needs and protocol requirements. Both electronic data capture (EDC) systems for electronic case report forms (eCRFs) or paper CRFs along with in-house development of database are available to meet customer’s needs.

The statistical framework is critical in clinical studies or even post-marketing supports which can affect the outcomes of the studies. At Bestat, the biostatistics team involve in not only the data analysis or producing statistical tables, figures and listings (TFL), but also in the protocol development stage.

Clinical event committee is an independent reviewing group to assess the either efficacy or safety of the clinical study. This group can also be delegated to evaluate the data (e.g. image) specified in the protocol independently.

Our dedicated team of medical writers have industry experience in the field of clinical trials and involve in various therapeutic areas and indications for drugs and medical device.

Quality assurance helps our customer to ensure the data are credible and accurate. During the conduction of a project, the quality assurance team delivers both in-house and on-site audits based on applicable regulations, GxP and SOPs. We provide possible approaches to correct the discrepancies and improve the quality of customer’s project.