Clinical Trials

From early R&D clinical development and regulatory activities through late-phase clinical trials, BioClever offers a full range of integrated product development services. Regardless of your point of entry, BioClever will craft a customized clinical and regulatory program providing seamless access to our full range of development services, all designed to meet your specific needs.

Clinical Trial Services:

Clinical Trial Design and Start Up

BioClever is experienced in a wide range of clinical trial designs including:

• Open-label
• Blind (single or double)
• Randomized
• Parallel-groups
• Crossover
• Placebo-controlled and/or comparator

Share your clinical trial idea with us and we will develop a concept sheet proposal.

Project Management

At BioClever, all our staff are from the clinical research sector. They have wide experience in management and consultancy methodologies and offer our clients quality service that will deliver projects on time and on budget.  Projects are thoroughly followed up throughout, and any potential risks are minimized as far as possible.

Clinical Monitoring

Our CRAs are experienced in working effectively with sites to ensure that patient recruitment and study milestones are met

Our annual staff turnover is low (less than 5%) and our employee satisfaction is high (90% of our people are happy and feel valued in their job*), so we can assure our clients that the same CRAs who start up a trial will be there at close-out.

Data Management and EDC

Our team of professionals is qualified to perform all the activities required to conduct a top quality clinical trial. They will design the CRF or eCRF, create and validate the database, manage and code all AEs and SAEs, and process and enter fully coded data according to international dictionaries.

Ennov’s Clinical software suite provides sponsors, investigators and patients with a comprehensive, end-to-end solution for the collection and management of all clinical trial data, whether structured or unstructured, from the earliest stages of planning through study conduct and close-out. The Ennov Clinical suite consists of Clinical Data Management applications (Ennov EDC, Ennov RTSM and Ennov ePRO) and Clinical Trial Management applications (Ennov CTMS and Ennov eTMF) that are available for use on the cloud or on-site. 

Statistics

All our studies are conducted according to standard operating procedures that comply with the ICH guidelines E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports). These procedures are implemented at all stages of the process, including protocol writing, statistical analytical planning (randomization, sample size calculation, etc.), statistical programming (reports and statistical analyses), and providing statistical consultancy to the medical community.

Data Standardization

CDISC is the standard system for submitting clinical data to regulatory agencies.  As a member of the CDISC, BioClever receives constant updates on SDTM implementation guidelines and ADaM development datasets

Medical and Scientific Writing

Our medical writing team is fully involved in R&D design, clinical writing, medical monitoring and biostatistics.

All processes involving clinical trial reporting are conducted according to the ICH:E3 guideline (Structure and Content of Clinical Study Reports), generating trustworthy and quality results for our clients.