General Legal Solutions Clinical Research:
Focus on Contracts

Confidentiality and Integrity at the Core

At Accelsiors Legal, we understand the paramount importance of confidentiality in the realm of clinical research. We specialize in crafting and managing Confidentiality Agreements and Clinical Trial Agreements with precision and care across more than 40 countries. Our team ensures that your intellectual property and sensitive information are safeguarded, upholding the highest standards of privacy and security.

Global Reach, Local Expertise

Our extensive network spans Europe, North America, Asia, North Africa, the Near East, Australia, and Latin America, enabling us to handle a large volume of Clinical Trial Agreements with unparalleled efficiency. Our seasoned legal professionals are well-versed in the local laws and regulations of each region, ensuring compliance and contributing to the success of your clinical trials.

Streamlined Contract Negotiations for Swift Turnarounds

We are committed to enhancing the quality and effectiveness of contract negotiations while significantly reducing turnaround times. Our approach is rooted in a thorough understanding of applicable laws and the utilization of pre-approved Sponsor authorizations and fallback contract language. This strategic method ensures adherence to legal requirements and expedites the contracting process, allowing your projects to move forward without delay.

Part 11 EIDAS Compliant Electronic Contract Management

Embracing technological innovation, Accelsiors Legal offers a full suite of Part 11 compliant electronic contract management services, including EIDAS compliant qualified electronic signatures and secure filing. Our proprietary electronic Trial Master File (TMF) system, ADAM, stands as a testament to our dedication to efficiency, security, and accessibility, ensuring that all your contract-related documents are managed with the utmost care and precision.

Comprehensive Vendor Contracting Services

Our legal expertise extends to vendor contracting, covering an extensive range of service providers such as Central Laboratories, Drug Packaging and Distribution Vendors, Central Imaging/Acquisition & Reporting Vendors, DSMB/DMC, Local Laboratories, and Diagnostic Units. Our team provides valuable counselling, ensuring that your collaborations are built on solid legal foundations, safeguarding your interests and contributing to the seamless progression of your clinical trials.

Navigating Data Privacy with Expertise

In the ever-evolving landscape of clinical research, safeguarding personal data has never been more crucial. Accelsiors Legal is at the forefront of providing robust Privacy solutions, ensuring that your research practices are not just compliant, but exemplary. We specialize in crafting Data Processing Agreements, Joint Controller Agreements, and ensuring thorough patient and staff consenting processes, all while providing expert counseling on data privacy issues.

Comprehensive Data Processing and Joint Controller Agreements

Our expertise extends to managing Data Processing Agreements with Sponsors, clinical sites, and vendors, ensuring that all parties are aligned and compliant with GDPR standards. We facilitate Joint Controller Agreements and Controller-to-Controller Agreements with clinical sites, creating a transparent and secure framework for data handling and protection.

Proactive GDPR Compliance and Impact Assessment

Guided by the expertise of our group Data Protection Officer (DPO), we provide counseling on GDPR compliance, data mapping, and conducting Data Protection Impact Assessments (DPIA) – an essential step for Sponsors under EU GDPR. Accelsiors Legal is poised to offer consultancy on how to conduct comprehensive DPIAs, assess risks, and implement the necessary technological and organizational measures to mitigate those risks and maintain data integrity.

Leveraging DPIAs for Efficient Compliance

Understanding the value of efficiency in clinical research, we highlight that once a DPIA has been conducted for one study, its templates and findings can be effectively utilized for other studies within the same regulatory region, such as the UK, ensuring a streamlined approach to compliance across multiple projects.

Consent Management

We implement robust consent management practices, ensuring that all data subjects are fully informed and their consents are obtained in compliance with GDPR requirements. Our systems are designed to document and manage consents effectively, allowing for easy retrieval and verification when needed.

Data Subject Rights Management

Accelsiors Legal ensures that all data subject rights under GDPR are respected and facilitated. We have established processes for efficiently handling data subjects’ requests, including access, rectification, erasure, and data portability, safeguarding their rights and maintaining transparency.

Security Measures

We prioritize the security of personal data in all our clinical research activities. Our security measures include encryption, access controls, and secure data transfer methods, ensuring the protection of data from unauthorized access, disclosure, or alteration.

Breach Notification Procedures

Accelsiors Legal has established comprehensive data breach response plans, ensuring timely notification to supervisory authorities and affected individuals in case of a reportable data breach. Our procedures are designed to minimize the impact of a breach and safeguard data integrity.

Training and Awareness

We are committed to fostering a culture of data protection awareness and compliance. Our ongoing training programs ensure that all staff involved in clinical trials are aware of their responsibilities and the importance of protecting personal data.

Data Retention and Deletion

Our data retention policies and procedures ensure that personal data is not kept longer than necessary and is securely deleted when no longer required, in accordance with GDPR mandates.

Data Transfer Mechanisms

Accelsiors Legal ensures lawful mechanisms are in place for transferring personal data outside the European Economic Area, utilizing instruments such as Standard Contractual Clauses or adequacy decisions to guarantee data protection.

Documentation and Record Keeping

We maintain comprehensive records of data processing activities, risk assessments, and compliance measures to demonstrate accountability and adherence to GDPR.

EU Legal Representative Services

As your EU Legal Representative, Accelsiors ensures adherence to Article 74 of the Regulation (EU) No 536/2014 of the European Parliament and of the Council dated 16 April 2014, known as the ‘Clinical Trials Regulation’ (CTR). Our expert team is dedicated to navigating the complex regulatory landscape, providing steadfast support throughout the entirety of your clinical trial.

UK Legal Representative Services

In the United Kingdom, Accelsiors CRO and Consultancy Services (UK) Ltd, based at 20-22 Wenlock Road, London, N1 7GU, United Kingdom (“Accelsiors UK”), is available to act as your UK Legal Representative. We ensure that your clinical trials are conducted in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, fulfilling all statutory requirements.

Swiss Legal Representative Services

Accelsiors AG, located in CH-6340 Baar, Bahnhof-Park 2, is poised to serve as your Swiss Local Representative (“Swiss Local Representative”), operating in full compliance with Art 2c of the Ordinance on Clinical Trials in Human Research (Verordnung über klinische Versuche; KlinV) and Art. 11b para 1 of the Administrative Procedure Act (APA) (Verwaltungsverfahrensgesetz, VwVG).

Latin American Legal Representative Services

Expanding our reach, Accelsiors now offers legal representative services in Latin America, ensuring your clinical trials meet all federal and state-specific regulatory requirements. Whether your study is based in any countries of South-America requiring the appointment of a local representative, our experienced team has the local knowledge and expertise to guide you through the complex regulatory environment, ensuring compliance and success.

With Accelsiors’ International Legal Representative Services, you are securing a partner that stands for excellence and compliance, facilitating successful clinical trial conduct across crucial global regions.

EU Data Controller/Processor Representative Services

For clinical trial sponsors not established within the European Union, Accelsiors offers invaluable support as your EU Data Controller Representative in line with Art 27 EU GDPR. By utilizing our vast network of corporate affiliates spread across European countries, we can represent both study Sponsors (controllers) and other involved parties (processors), all under the vigilant supervision of our Data Protection Officer (DPO), who is registered in every jurisdiction and for all entities.

UK Data Controller/Processor Representative Services

Accelsiors ensures seamless compliance with Art 27 UK GDPR for Study Sponsors outside the United Kingdom through our UK Data Controller Representative Services. Navigate the UK’s unique data protection landscape with confidence, meeting every regulatory requirement head-on.

Turkish Data Controller Representative Services

Extend your compliance reach into Turkey with Accelsiors. Our Turkish Affiliate, Accelsiors Istanbul Klinik ve Saglik Hizmetleri LŞ, is here to assist Study Sponsors in adhering to KKVK regulations, including necessary registrations in the Turkish Data Controller’s Registry “VERBIS”.

FADP Data Representative Services

Accelsiors ensures seamless compliance with the Swiss Federal Act on Data Protection (FADP) for Study Sponsors with seat outside Switzerland in line with Art 14 FADP through our Swiss Data Representative Services.

Unparalleled Support for Orphan Drug Designation

Navigating the path to orphan drug designation is a critical step for many SMEs. Accelsiors offers exceptional Scientific Advice and Protocol Assistance at the European Medicines Agency (EMA), guiding you through the complexities of the process. Our seasoned experts are here to help you make informed decisions, ensuring your product stands the best chance of receiving the coveted orphan drug status.

Tailored Counseling Services for SMEs

We understand the unique challenges faced by SMEs in the pharmaceutical industry. That’s why we offer specialized counseling services, providing you with the knowledge and support needed to thrive. From regulatory compliance to market strategy, our team is dedicated to your success.

Unlocking Financial and Regulatory Incentives

The EMA provides a range of incentives for SMEs, aimed at reducing the financial burden and accelerating the development and marketing of medicines within the EU and EEA. Accelsiors is your guide to unlocking these benefits, including:

• Procedural Fee Incentives: Significant reductions or exemptions from standard fees for various regulatory procedures.
• Pharmacovigilance Fee Incentives: Tailored fee structures to ease the financial load of pharmacovigilance activities.
• MeDRA Fee Waivers: Access to the Medical Dictionary for Regulatory Activities (MeDRA) without the standard fees, facilitating smoother regulatory interactions.
• Translation Assistance: Support in navigating language barriers, ensuring your documentation is precise and compliant.
• Financial Advantages: Leveraging the SME status for financial benefits and streamlined regulatory processes. Learn more about the financial advantages of SME status at EMA.

With Accelsiors’ SME Services, the path to pharmaceutical innovation has never been clearer. Partner with us, and unlock a world of opportunities, guidance, and support, tailored specifically for small and medium-sized enterprises in the fast-paced and challenging realm of drug development. Your success is our mission.

Australian Local Sponsor Services:

Expanding your research to Australia offers immense potential, an abundance of treatment-naïve patients, leading medical institutions, and financial incentives. But navigating Australia’s clinical trial regulations can be a boomerang without local know-how.

As your on-the-ground experts, Accelsiors guides US pharma companies through Australia’s unique requirements, so you can harness the benefits of conducting trials in this premier destination. Our experienced Regulatory Consultants Provide:

In-depth guidance on local sponsor roles and selection: We’ll help you identify the right partner to take on mandatory compliance duties.

End-to-end support for TGA submissions and approvals: We’ll liaise with regulators, so your trial startup goes as smooth as Vegemite.

Seamless integration of US and AU standards: We’ll ensure quality and consistency across sites to maximize your trial’s value.

Maximization of R&D tax incentives: You can pocket up to 43.5% in offsets and credits. We’ll ensure you get your full share of benefits!

Take the leap down under with an experienced partner! From selecting top-notch trial sites to qualifying for R&D incentives, we’ll help you successfully ride the wave of Australia’s research opportunities. G’day to new trials!

In line with your needs, Accelsiors is ready for agreed responsibility allocations in Complete drug development programs / EU incentives / SME incentives …

There may be several reasons why a Sponsor may appoint Accelsiors as Co-Sponsor. One may delegate a CRO with a complete drug development program, while other would like to seek benefit of Accelsiors SME status at EMA. Accelsiors is ready for entering into co-sponsorship agreement between study sponsors and Accelsiors relating to task allocation between the parties in the form of co-sponsorship of the clinical trial in order to assume defined, specific sponsor responsibilities.

Transcending Borders in Healthcare Transparency: Your US and EU Compliance Catalyst

Navigating the labyrinth of healthcare transparency can be daunting. Accelsiors is your trusted ally, offering bespoke legal services that meticulously align your operations with the rigorous standards of the US Sunshine Act and the complex mosaic of EU transparency regulations.

In the US: A Beacon of Compliance – Illuminate the path of compliance with our expert guidance tailored to the Sunshine Act’s stringent reporting protocols. We help demystify the process, ensuring every payment and transfer of value to healthcare providers is transparently disclosed, leaving no room for oversight.

In the EU: Your Strategic Compliance Partner – Our expertise spans the multifaceted landscape of EU regulations, including the EFPIA Disclosure Code and national laws like France’s Sunshine Act. Accelsiors offers strategic advice to help you deftly navigate each country’s unique transparency requirements.

Our Comprehensive Suite of Services:

• Gap Analysis and Risk Management: We delve into your current practices to identify compliance gaps and potential risks in both the US and EU frameworks.
• Policy and Process Enhancement: Our tailored recommendations aim to refine your policies, streamline your processes, and optimize your systems for seamless transparency.
• Registration and Reporting Facilitation: From initial registration to systematic data collection and reporting, we’re with you every step of the way.
• Audit Excellence and Corrective Strategies: We conduct thorough audits and formulate effective corrective actions to bolster your compliance stature.
• Legal Advocacy and Dispute Resolution: Should disputes or appeals arise, our seasoned attorneys stand ready to champion your cause.
• Customized Training Solutions: Equip your team with the knowledge and skills they need through our specialized training programs, designed to foster a culture of compliance.
• Regulatory Vigilance: Stay ahead of the curve as we monitor and interpret the latest changes in US and EU transparency requirements.

At Accelsiors, we’re more than legal advisors; we’re your partners in cultivating and maintaining ethical relationships with healthcare providers. With our globally attuned legal acumen, your compliance is in capable hands.

Embrace Compliance with Confidence—Contact Accelsiors Today.

Your journey towards transparent and ethical healthcare interactions begins here. Reach out to us, and let’s set the cornerstone for enduring compliance together.