CLINICAL & PRECLINICAL TRIALS

Human Efficacy trial

EVIDILYA has the capability to manage all over the world Mono and Multicentric cross-countries Clinical Trials involving the identified target population (Healthy-Sub-Healthy and Diseased Subjects) with a fast-effective process in the field of:

• Product Absorption, Distribution, Metabolism and Excretion (ADME) studies;
• Product Efficacy studies;
• Prophylactic product studies;
• Diagnostic product studies;
• Surgical procedures studies.

We are currently covering the geographical area around the world conducing both Phase I-II-III till Post Marketing studies. We directly interact with our partners and clients, designing the best strategy of trial implementation including cross-over design, parallel controlled randomized design allocating the double-checked statistical outcomes for a minimized, blocked or stratified randomization process.

Our project planning team provide smart solution in Study Outline Development, Protocol design, Definition of Objective and outcomes as well as the coordination and implementation, thanks to the expertise of our global and local team.

With our extensive clinical development experience, we are able to offer to our clients appropriate allocation of resources, innovative strategies and tools bringing commercial insights into clinical development, resulting in more efficient studies meeting clients’ needs and providing higher quality data to help improve products’ success in the marketplace.

Ten years of experience in the field of clinical trial design and implementation allow us to perform a complete research solution or provide specific service to realize tailor-made research program:

• Strategic Patient Recruitment service: we offer innovative, customized services for patient recruitment needs. Our unique services include the development and optimization of effective advertisement campaigns and enrolment strategies strictly following ethical principles and country based legislations. Slow patient recruitment is by far the most common cause of delays in clinical studies. We use a well-defined process when selecting sites to ensure a high probability of reaching the required number of patients for the study within the specified timeline.
• Medical Writing Support: our team of dedicated, professional medical writers can provide a complete writing service to clients around the globe, spanning the generation of individual documents to extensive medical writing programs. We ensure that the medical writer assigned to each project team has the required document and health area expertise to fulfill each sponsor’s needs. A complete medical writer service: we are able to follow your activity from synopsis and protocol finalization, to clinical report and peer-review journal study publication.
• Regulatory and Ethics Committee submissions and contacts: a solid regulatory plan can help you conduct the right studies at the right times, attain regulatory approval sooner, and, ultimately, market your product sooner. We have many years’ experience of handling the regulatory and ethics committee submissions and contacts at the global level. Our knowledge of local ethics and regulatory requirements is invaluable in reducing approval process timelines.
• Clinical Monitoring and Site Management: thanks to our global network of Clinical Research Associates and the advanced informatics tools in place, we can perform standard on-site Monitoring activities as well as in house remote Data Monitoring. Our project teams collaborate closely with our sponsors, and maintain close contact with the sites, supporting each investigator in order to maximize study quality and performance.
• Study Management: comprehensive project management is the key to the success of any study. We have teams of experienced Project Managers present all over the world. Our Project Managers maintain an overview of all aspects of the study, working closely with the study team to ensure control of project scope, quality, budget and timeline.
• Biometric support: a well designed statistical analysis plan improves the quality of clinical trial reporting and raises confidence in study findings. Our biostatisticians understand the subtleties of study design and statistical techniques such that the trial can be designed and optimized for success while, at the same time, balancing timelines and budget constraints. Whether it’s sample size calculations, study design development, statistical analyses, or data interpretation, Evidilya can tackle even the most complex projects and deliver fast, accurate, and cost-effective solutions.

Post marketing evaluation

As a requirement for the approval or continued marketing of products, Post Marketing and Regulatory Commitment studies may provide additional and helpful information to our partners in products amelioration, seeking to maintain the already acquired marketing segment or enlarging it, adding significance to the intrinsic and scientific value of their own products.

Safety and Surveillance Studies

The monitoring of the safety of products destined for human use is a key concern throughout the product’s lifecycle as well to have the rights to prove some beneficial effect.

EVIDILYA is able to identify the best safety assessment protocol design, answering to the key parameters to be tested in order to ensure product safety and tolerability in human organism. Furthermore, the design allows evaluation of known safety issues for both short and long-term safety profile of a product.