Partner

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 950 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.

Vault Clinical Suite:
Vault Clinical Suite transforms clinical operations and clinical data management with the most comprehensive suite of clinical solutions, offering EDC, coding, data management, study start-up, eTMF, CTMS, and payments on a single cloud platform. Life sciences companies can increase visibility, streamline end-to-end processes, and improve how sponsors, CROs, and sites work together throughout the clinical trial process.

For more information about Veeva Systems Inc., visit: https://www.veeva.com/eu/

Flex Databases is a eClinical software provider. They develop and provide e-Clinical platform with a number of modules including CTMS, LMS, TMF and other products.

Flex Databases enables clients to take clinical trials to the next level with eClinical platform, organized data, transparent processes and compliance with global regulations. All work done in one place: measured, organized, reported to take business to the next level.

For more information about Flex Databases visit: https://flexdatabases.com

Viedoc Technologies AB is a comprehensive cloud-based platform built to improve the efficiency of conducting all clinical trials. Since 2003 Viedoc Technologies AB has been used in over 3 000 trials in more than 75 countries in all therapeutic areas and clinical phases.

Created by industry professionals with decades of experience, Viedoc Technologies AB blends innovation with design to simplify their clients` workday. Viedoc Technologies AB meets all applicable regulatory standards, including ICH GCP, 21 CFR part 11, HIPAA.

Viedoc Technologies AB has offices around the world. With its headquarters in Uppsala, Sweden also has offices in Philadelphia, Tokyo and Shanghai as well as salesforce spread out in many countries throughout Europe.

For more information about Viedoc Technologies, visit: www.viedoc.com

MyData-TRUST supports the Life Sciences Industry in leveraging Data Protection compliance.

Unique combination of IT, Legal and Clinical experts providing a full coverage of services dedicated to Life Sciences with strong Data Protection expertise: consulting, implementation and solution for GDPR, HIPAA and Privacy Shield.

The aim of MyData-TRUST consists in providing strategic, operational and organizational support, making an important contribution both legally and technically to the success of the Data Protection implementation and the company as a whole.

For more information about MyData-TRUST, visit: www.mydata-trust.com

Trials24 accelerates patient recruitment for clinical trials globally, helping CROs and biopharmaceutical companies find patients beyond their sites’ reach. Trials24 commonly contributes 20-65% of all randomized patients, shortens the recruitment timeline by 6 months or more, and delivers a return on investment (ROI) of 7-12x for their campaigns.

Trials24’s approach centers around online patient recruitment, with a rigorous triple-prequalification process of patients before referral. The result: sites screen up to 40% of Trials24’s referrals.

To ensure the predictability of a campaign’s successes, timelines, and costs, Trials24 offers a Patient-Reported Feasibility Study approach based on real-world data (RWD). Trials24 measures the patient population’s eligibility rate specific to the study protocol and builds a recruitment cost model that projects patient enrollment costs. This RWD-based scientific approach ensures customers know the campaign will be ROI-positive before implementation.

For more information about Trials24, visit: trials24.com

With four research units in the largest metropolitan regions of Germany and a total capacity of 200 in-house beds, CRS offers its clients innovative concepts and intelligent solutions in the field of early clinical development – from First-in-Human, Proof-of-Concept in patients. As a healthcare partner, CRS is highly committed to make a contribution in the development of new drugs that improve patient’s life. Early-phase clinical development is the DNA of CRS. Utilizing state-of-the-art technology and proven methodologies, CRS generates high-quality data and provide valuable insights.

CRS provides extensive expertise and outstanding early phase clinical services that deliver premium value to our customers, guaranteeing highest safety to volunteers and patients.

For more information about CRS, visit: https://crs-group.de/

Founded in 1993, EBD Group is an international life science consultancy with offices in California, Munich and the UK, providing Business Development and Drug Development services to pharmaceutical, biotechnology and medical device companies.

EBD’s consultants have strong pharmaceutical and biotechnology backgrounds, and the Group’s services have helped numerous US and European life science companies form a productive bridge between the two continents.

Drug Development - from Clinical to Phase IV
Bio-Pharmaceutical Development: Strategic Clinical Plans - Labeling practices - Pharmacovigilance - Regulatory Consultations - Interactions with FDA and other Regulatory Authorities - Selection of contract research organizations (CROs) - Regulatory Documents (IND, NDA) and Protocol and Report Preparation

www.ebdgroup.com

FHR Consult offers a diversified range of expert and hands-on consulting support for biotech, VC and pharmaceutical companies in the areas of partnering, licencing, strategy, management, financing and competitive intelligence.

The focus is centered particularly on all aspects of research, development and commercialization of biologicals such as antibodies and other targeted medicines. FHR works with an international network of partners and experts to give clients the broad coverage, quality advice and tangible support needed for risk-balanced, fast decision-making in complex corporate processes.

For more information about FHR Consult, visit: www.fhrconsult.com

FGK Pharmacovigilance GmbH (FGK PV) is a growing offspring of FGK Clinical Research GmbH. FGK PV is run by seasoned experts, who are bringing with them knowledge of authorities on both sides of the Atlantic, time-proven safety experience and a steady hand. FGK PV offers:

• Management of Adverse Events and Signals from a variety of sources
• Preparation of periodic safety update reports
• Preparation of ad hoc safety reports, opinions, or statements specifically tailored to requests of competent authorities
• Safety profile characterization of medicinal product
• Planning of pharmacovigilance activities to increase knowledge about the safety profile of the medicinal product
• Management of risk minimization activities, including assessment of effectiveness of these activities

www.fgk-pv.com

FGK Representative Service acts as a legal representative for pharmaceutical and biotechnology companies which have no subsidiary within the EU and which submit regulatory applications to the European authorities.

The Clinical Trials Directive (2001/20/EC), implemented May 1, 2004, requires that a legal representative of the sponsor be established in the EU for all clinical trials conducted in the EU. This is why it is no longer possible for a company outside the EU to conduct a clinical study without an entity representing them in the EU.

Directive 2001/83/EC requires that for a marketing authorization application in the EU the applicant has to be established in the EU.

Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product from the EMEA must be established in the EU.

As of 26 May 2021 the new Regulation (EU) 2017/745, the Medical Device Regulation (MDR) will come into application for new clinical investigations with medical devices. EU member states will need to decide whether pursuant to Article 62. 2 (1) of MDR a legal representative of non-EU sponsors should be appointed or pursuant to Art 62. 2 (2) MDR a contact person in the EU will be sufficient. FGK Representative Service will provide both services for sponsors not established in the EU.

www.fgk-rs.com