Services Consultancy in product development

Legal, GDPR and
Representation Services

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Accelerating Clinical Trials Worldwide With Expert Legal Guidance

Streamline global clinical trials and mitigate risk through Accelsiors Legal’s full-service support

When bringing new therapies to market, you need an experienced legal partner who deeply understands the intricacies of clinical development. Accelsiors Legal provides tailored full-service support to accelerate your global clinical trials in a compliant manner.

Our attorneys have extensive backgrounds in biopharma research and regulations across 40+ countries. We offer practical guidance and representation to speed your development timelines.

“Accelsiors Legal helped us navigate complex international regulations and saved over 6 months in trial delays.” – Director of Clinical Operations, Pharma Company

Legal Services in support of Global Clinical Trials

  • Clinical Trial Agreements
  • Regulatory Compliance
  • Data Protection
  • Technology Transactions
  • Transparency Initiatives
  • Vendor Oversight
  • Intellectual Property Management
  • Ethics and Patient Consent
  • Product Liability and Risk Management
  • Corporate and Business Transactions
  • Export and Import Compliance
  • Insurance and Indemnification
  • Employment and Labor Law Compliance.
Ask Accelsiors' Clinical Trial Regulatory Experts

Accelsiors Legal – Your Global Legal Partner

Combining real-world expertise with in-depth understanding of clinical landscapes

Key Differentiators:

  • Globally connected teams with local knowledge of country-specific regulations
  • Practical guidance aligned with clinical realities
  • Seamless collaboration between our legal and clinical experts
  • Proactive risk assessment and mitigation
  • Innovative approaches to complex legal issues
  • Advanced legal analytics and technologies
“The Accelsiors Legal team’s practical guidance aligned perfectly with our on-the-ground trial needs.”
– VP of Clinical Development, Biotech Company

Don’t settle for legal teams with only theoretical knowledge. Our attorneys provide real-world expertise.

Contact Accelsiors Legal today to learn how our tailored guidance can accelerate your global clinical trials while minimizing risk. We look forward to collaborating with you.

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Legal Consultancy LEGAL, GDPR AND REPRESENTATION SERVICES

Accelsiors Legal and Data privacy teams provide Legal and Privacy consultancy services to support you to become and to stay compliant with regulatory requirements
Legal Services

Confidentiality Agreements, Clinical Trial Agreements drafting & management in 40+ countries, Vendor contracting, Counselling on compliance issues ...

  • Managing Sponsor confidentiality contracting (CDAs/NDAs,)
  • Managing a large volume of clinical trial agreement, in 40+ countries in Europe, North America, Asia, North-Africa/Near East, Australia and Latin America
  • Ensuring adherence to applicable laws, improving contract negotiation quality, effectiveness and reducing turnaround time based on pre-approved Sponsor authorizations and fallback contract language, Full electronic contract management including contract signature (EIDAS compliant qualified electronic signature) and filing (see Accelsiors’ proprietary electronic TMF ADAM).
  • Counselling Vendor contracting (including Central Laboratories, Drug packaging and distribution vendors, Central Imaging/Acquisition & Reporting Vendors, DSMB/DMC, Local Laboratories and diagnostic units etc.)
GDPR Services

Data Processing Agreements, Joint Controller Agreements, patient & staff consenting, Counselling on Data privacy issues, Data Protection Impact Assessment ...

  • Data processing agreements with Sponsor, clinical sites and vendors,
  • Joint controller agreements and controller-to-controller agreements with clinical sites;
  • Counselling on GDPR compliance (with involvement of our group DPO), data mapping and Data Protection Impact Assessment (DPIA) mandatory for Sponsor under EU GDPR. Accelsiors, on Sponsor’s request, may offer consultancy on how to conduct a proper DPIA, risk assessment, what technological and organizational measures to implement in order to mitigate risks and set them to an acceptable level. For Clarity, if DPIA has already been conducted for one study, the templates can be used for other studies in the UK and vice versa.
Legal Representative Services

In order to support the study conduct in the EU, UK and in Switzerland, Accelsiors is supporting Study Sponsors in their compliance by providing auxiliary legal Representative services in these countries ...

  • EU Legal Representative Services: Accelsiors agrees to act as Sponsor’s EU Legal Representative in accordance with Article 74 of the Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 (‘CTR’)
  • UK Legal Representative Services: Accelsiors UK entity, Accelsiors CRO and Consultancy Services (UK) Ltd (20-22 Wenlock Road, London, N1 7GU, United Kingdom) (“Accelsiors UK”) can be appointed as Sponsor’s UK Legal Representative. statutory requirement in line with the Medicines for Human Use (Clinical Trials) Regulations 2004
  • Swiss Legal Representative Services: Accelsiors AG, CH-6340 Baar, Bahnhof-Park 2, to act as Sponsor’s Swiss Local Representative (“Swiss Local Representative”) in accordance 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).
Data Controller / Processor Representative Services

Accelsiors is supporting Study sponsors with EU GDPR, UK GDPR and KKVK compliance by providing Data controller and Data processor representative services ...

  • EU Data Controller/Processor Representative: If the Sponsor of a clinical trial is not considered to be established in the EU under EU GDPR, it will need to appoint a Data Controller’s Representative in the EU in line with Art 27 EU GDPR. Accelsiors can take advantage of any of its corporate affiliates in the countries, where the Study is running, to be appointed as EU Data Controller Representative and may act as representative on behalf of the study Sponsor (controller) or any other party involved (processor). All entities are covered by our DPO who is registered in all jurisdictions / for all entities.
  • UK Data Controller/Processor Representative: Study sponsor not established in the UK will need to appoint a Data Controller representative also in the UK (in line with Art 27 UK GDPR).
  • Turkish Data Controller Representative: Accelsiors will support Study Sponsors for their KKVK compliance in Turkey, through its Turkish Affiliate, Accelsiors Istanbul Klinik ve Saglik Hizmetleri LŞ including registration in Turkish Data Controller’s Registry „VERBIS”
Local Sponsor Services

Bring Your Clinical Trials Down Under with Confidence ...

    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 OZ-perienced 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!

SME Services

Scientific Advice (protocol assistance) at EMA for orphan drug designation, and Counselling services for small and medium-sized enterprises (SMEs) ...

The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorization regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).

This covers:

  • Procedural fee incentives
  • Pharmacovigilance fee incentives
  • Medical dictionaries (MeDRA) for regulatory activities fee waiver
  • Translation assistance

Financial advantages of SME status | EMA (ema.europa.eu)

CO-Sponsor Services

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

There may have 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

Accelsiors’ expert team
is ready to help you
to comply with the legal regulations and requirements set by law in clinical drug development. Worldwide.

Let us accelerate your clinical drug development program!