Medical writing

Understanding what makes each therapeutic and medical scientific area unique, combined with deep scientific and research knowledge in those areas, can lead to better study outcomes for innovative products. With our expertise in all major medical areas, we can provide valuable insight and support for your project – from the protocol design, site recruitment and retention to analyzing and publishing comprehensive and meaningful results. Our medical writing team consists of native English speaker and other native speakers, all of whom are highly qualified in either medicine or life sciences, with many years of experience. This network of writers allows us to provide reliable and valuable support for clients’ scientific needs.

Our team of dedicated, professional medical writers provides a complete writing service to clients worldwide, spanning the generation of individual documents to extensive medical writing programmes. We ensure that the medical writer assigned to each project team has the required health document and health area expertise to meet each sponsor’s needs.

Data monitoring

EVIDILYA monitors our leaders in their respective fields. We have years of diverse experience across many health areas, holding industry certifications, to ensure quality and efficiency of study monitoring. A unique advantage of our monitors is that they have intimate knowledge of local customs and regulations; this means that the efficiency of the monitoring process is greatly enhanced. EVIDILYA ensures that patient welfare is also maintained, clinical protocol is adhered to and Good Clinical Practices are utilized and documented. Our monitoring team will enhance the quality of a research programme and will stay abreast of any potential issues that could otherwise side-track the project from moving forward.

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.

Pre-clinical and clinical network

EVIDILYA has a network of clinical investigators located around the world.

Partner site programme is aimed at moving away from using solely tactical relationships when these relationships have to be invented. Every study should be focused on mutual commitment and improved productivity and efficiency, with multiple studies. Partner sites benefit by having:

• Access to a steady flow of work and more new options for your patients. We act as a communication link between the sponsor and the clinical site getting everybody connected;
• Training, tools and ongoing assistance to help the site in site’s clinical trials performance maximization;
• Investigator and sites selection based on the capability, commitment and highest standard quality recruitment service;
• Clinical staff motivation is a crucial point, especially for FMCG Clinical Research where the so-called “butterfly effect” needs to be transformed into strong validation;
• A strategic recruitment unit to identify the most suitable source of subjects and meeting their compliance for a faster recruitment rate from healthy, sub-healthy, diseased subject.

EVIDILYA Central Labs are accredited by the highest industry standards. In fact, all laboratory locations are, ISO17025 certified and GLP compliant.

Project planning and coordination

EVIDILYA's project planning team can provide time and expertise in: study outline development, protocol design and definition of objective and outcomes. We also provide global project coordination and implementation, thanks to our experience in global coordinating and teams of local clinical project managers.

Efficient planning and monitoring of clinical research projects is a critical point of a products’ lifecycle. With our extensive clinical development experience, we are able to offer our clients appropriate allocation of resources and innovative strategies and tools. We bring commercial insights into research programme development, resulting in more efficient studies meeting our clients’ needs and providing higher quality data to help improve products success in the marketplace.

We understand that every study is different, and our dedicated operational experts can help design the right operational strategy to achieve the unique objectives of our clients’ programmes.

• Experience: project managers with more than 5 years of experience, working together for global coordination;
• Leadership and speed: throughout an integrated communication system, we provide fast and effective answers and problem solving skills for scientific program development and implementation;
• Development of project plan: resource allocation, monitoring plan, monitoring manual, CRF completion guidelines, tracking tool creation and customization;
• Project management during study conduction: review of trip reports, site communication, follow-up of outstanding issues, sponsor communication, resource management;
• Sponsor interaction: scheduled agenda, day by day issues communication and problem solving with sponsor, meeting minutes and maintenance of central files, sponsor follow up.

Publication planning

Beyond the development of a study report, publication of study results in a peer-reviewed journal is one of the best ways for your product to be exposed to medical professionals and consumers alike. Numerous publication planning activities occur after a trial is complete. Selection of a peer-reviewed journal is made by considering many different factors, including: registration requirements, impact factor, length of peer review/time to publication, sponsor urgency for publication, manuscript rejection rate, publication costs, target audience and size of audience, indexing in Medline and marketing needs.

We identify journals that are reputable and where the study has a strong chance of being accepted. EVIDILYA has an established record of publications across a broad range of therapeutic areas.

Quality assurance

An internal quality assurance organization is empowered to ensure that all studies are compliant with the International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) and follow applicable Standard Operating Procedures (SOPs). Our quality management department issues a quality management plan for each new study. These outline the quality procedures that have to be implemented during the clinical trial, including regular scheduled audits and spot checks for the study. If needed for a specific product and/or specific countries, quality guidelines and/or standards are applied.

All hospitals, universities and institutions EVIDILYA works with have standards in place for quality assurance of all procedures and processes to conduct: clinical trials (GCP), laboratory analyses (GLP), monitoring, reporting and data storage, as established by local standards and certified by local authorities.

Regulatory guidance

Regulatory guidance is a crucial component of a successful clinical research programme. 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. Whether your product is a dietary supplement, a medical device or a pharmaceutical compound, EVIDILYA can help you navigate the regulatory landscape to achieve success.

Our strategic support consists of:

• Experience: specific commitment are put in regulatory landscape identification and translation in regards to specific categories such as novel food, food for special medical purposes, medical device and cosmetics;
• Leadership: protection of human subjects is outstanding in the execution of clinical trials. Furthermore, IRB/EC submission and approval are crucial milestones in the clinical trial lifecycle. Selection of the appropriate IRB and submission of complete and accurate study documentation as well as IRB/EC close follow up can speed up the process of trial approval;
• Connection with IRB/EC networks: EVIDILYA has built strong relationships with many academic and central IRBs/ECs over the years to ensure utmost flexibility, by selecting an IRB with a proven record of protecting the rights of subjects as well as timely reviews and approvals. Our distinctive feature is that we have enriched our database of clinical sites and related IRC/ECs; we anticipate those who have shown passion for and trust in FMCG clinical research;
• Quality assurance process: EVIDILYA is following the principles of ICH and GCP and adherence to the applicable regulatory or legal requirements.

Statistics

A solid biostatistical foundation underpins all high-quality clinical trials. The biostatistic approach utilized for a clinical trial must undergo scrutiny by journal peer reviewers as well as regulators. A well-designed statistical analysis plan improves the quality of trial reporting and raises confidence in study findings. EVIDILYA biostatisticians understand the subtitles of study design and statistical techniques. Trials 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.

Our statistics team improves the quality of data by coming up with specific designs for experiments and survey sampling. Statistics provides tools for prediction and forecasting the use of data and statistical models. The whole biostatistic process is inclusive of:

• Determination of adequate statistical analysis and development of SAP;
• Simulation studies to corroborate chosen endpoints;
• Sample size and power analysis;
• Generation of randomization list;
• Interim and final analysis of study data;
• Participation in data safety monitoring boards;
• Preparation and representation of client case before regulatory authorities;
• Customized SAP (statistical analysis plan);
• Mock tables, listing and figures (TLF).

Services for Participants Enrolment and Management

Phygital Crowd strategies

We provides innovative, customized services for subject recruitment needs. Our unique services include the development and optimization of effective advertisement campaigns and enrolment strategies, which strictly follow ethical principles and country-specific legislations.

It’s crucial, based on study design and the health area involved, to understand the most effective subject source. The trends may drive the consumer to participate in a clinical study. Our specially designed patient recruitment platform increases recruitment efficiency and closely monitors patient flow throughout the enrolment process. Our services are comprised of many components:

• Awareness campaign, utilizing the full spectrum of advertising channels;
• Clinical sites subjects database;
• Evidilya subjects database;
• Online and call center pre-screening;
• Patient identification via national association;
• Community outreach and patient organizations;
• Clinical sites material (posters, flyers, other site material).

By continuously monitoring the success of the campaign and by rapidly optimizing it, the effectiveness of our recruitment strategy might speed up the recruitment rate, meeting clinical trial and sponsor timelines.

Armonia Community

An evolving Environment, powered by Evidilya, that provides communities with the opportunity to participate in research studies, in collaboration with a team of medical specialists in selected centers.
Learn more: https://armoniacommunity.com/

Concierge Service

D-T-P Concierge service and Participant Remote Support: CONNEXT™, a dedicated contact center with CRAs/specialists that constantly follow up for Data Entry verification and subject support.

Trial Start up activities

Post-market surveillance including clinical follow-up, compliance and vigilance handling, impacts on all aspects of the quality management system. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures, applicable to all products.

Thanks to a highly-skilled and specialized team, EVIDILYA is the ideal partner for the management of its customers post-marketing vigilance systems. We are able to assist when our clients need complete outsourcing of activities, as for specific processes related to post-marketing requirements.

We provide customized solutions, in accordance with the current legislation, working flexibly and seeking to reduce business costs. Our services include:

• Pharmacovigilance;
• Medical device vigilance service;
• Cosmetovigilance service.

Post-market survey

Post-market surveillance including clinical follow-up, compliance and vigilance handling, impacts on all aspects of the quality management system. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures, applicable to all products.

Thanks to a highly-skilled and specialized team, EVIDILYA is the ideal partner for the management of its customers post-marketing vigilance systems. We are able to assist when our clients need complete outsourcing of activities, as for specific processes related to post-marketing requirements.

We provide customized solutions, in accordance with the current legislation, working flexibly and seeking to reduce business costs. Our services include:

• Pharmacovigilance;
• Medical device vigilance service;
• Cosmetovigilance service.

Vendor management

With growing reliance on third party providers in clinical trials, the need for effective selection and oversight of vendors is more important than ever. A CRO must consider the growing regulatory expectations for a quality systems-based approach to GCP compliance, to ensure quality support and satisfy sponsors’ request.

EVIDILYA can support your activity, ensuring the selection and control of all vendors involved in a research program, and improve study quality, cost and speed. See how we can boost your activity:

• Gain and improvement of control over your vendors;
• Optimization of spending by understanding your vendor spending;
• Understand organizational skills to manage vendors;
• Reduction of risk when using vendors;
• Ensure vendor management best practices.