• IDEA Regulatory
• Metal Box Factory, 30 Great Guildford Street, Borough, SE1 0HS
• Telephone: +44 (0) 20 392 10201
• Email: info@IDEARegulatory.com
• www.IDEARegulatory.com

The following information is needed to draw up a customised cost proposal for legal representation:

• Current Investigators Brochure
• Current Protocol/Synopsis
• EudraCT and IND numbers (if available)
• Number of Subjects & Sites*
• Trial Locations (countries)*
• Expected timelines
• Study Start (FPFV/FPI)
• Study End (LPLV/LPO)
• Duration of Treatment with IMP

*within the EU and in total for the whole trial internationally. The sponsor may wish to sign a Confidentiality Agreement (CDA/NDA) before disclosing this information.

No, for a ballpark legal representation quote, all that IDEA Regulatory require is:

• Study Title
• Number of Subjects & Sites*
• Trial Locations (countries)*
• Study drug name
• Indication(s) under investigation
• Expected timelines
• Study Start (FPFV/FPI)
• Study End (LPLV/LPO)
• Duration of Treatment with IMP

*within the EU and in total for the whole trial internationally. The sponsor may wish to sign a Confidentiality Agreement (CDA/NDA) before disclosing this information.

Requirement in Article 19 of the EU Clinical Trials Directive (Directive 2001/20/EC):

“This Directive is without prejudice to the civil and criminal liability of the sponsor or the investigator. To this end, the sponsor or a legal representative of the sponsor must be established in the Community.”

If the Sponsor does not have an office or registered address in the EU and they wish to perform clinical trials in the EU they must have a legal representative who is established within the EU. This is similar to the requirement by the FDA for a ‘US agent’ for non-US sponsors submitting INDs/NDAs in the USA.

Without a Legal Representative the trial will not be approved by the Regulatory or Ethics authorities.

The Legal Representative takes on the position of the sponsor with regard to civil and criminal liability in the EC including responsibilities for liability for trial conduct, and forms a local point-of-contact for the EU regulatory authorities to which they can address formal correspondence and where, if necessary, notice of due process can be served.

If the Sponsor does have an office/registered address in the EU they do not need a legal representative.

Our fees are based on the level of service provided making them flexible according to your needs.

The costs involved for legal representation as a standalone service vary depending on the clinical phase, number of subjects, participating countries, investigational product and its indication. The costs will directly reflect the time we will need to spend in order to fulfil our duties as your legal representative. Fees for legal representation are usually charged per study (protocol).

There is a one off set-up fee to cover the cost of our safety/risk analysis of the trial. This is charged on signature of the work order.

A monthly maintenance fee is charged from the month in which the first CTA/EC submission is made in the EU, until the month of submission of the final end of trial declaration submission in the EU. A smaller retention fee is then billed until the Clinical Study Report Summary is submitted to the authorities and our official duty as Legal Representative ends.

As legal representative, IDEA Regulatory takes on legal responsibility for the GCP, regulatory and ethical compliance of the trial in the EU. The maintenance fee covers our liability for this, our running costs and also includes the various tasks carried out by IDEA Regulatory in the role of Legal Representative (e.g. co-signing investigator contracts and power of attorneys, deadline reminders, and compliance advice). We do not bill our time additionally for tasks within this scope allowing you to easily manage your budget.

Yes, preferential rates are available for returning clients and sponsors requiring legal representation for multiple studies. We also offer discounted rates to sponsors whose Orphan Drug Designations we hold in the EU. These will be automatically included in any quote generated.

The competent authorities, ethics committees and EudraVigilance must be informed of this change (as a minimum). Certain countries may also require additional changes to documentation (e.g. investigator and site contracts in Poland). IDEA Regulatory will need to liaise with the previous Legal Representative to obtain all of the necessary paperwork.

There are no extra charges from IDEA Regulatory for this service.

Not necessarily. If the EU branch are not comfortable performing this task, are not suitably equipped (i.e. only have manufacturing facilities with no regulatory or clinical personnel), or if having them perform this could potentially cause a conflict of interest or IP risk (due to country specific partnership agreements etc.), the role of legal representative can be outsourced to an external party, such as IDEA Regulatory.

The Clinical Trial Directive does not specify standards for legal representatives, other than that they must be established in the Community, meaning that they must be a company with at least one registered address in the EU. However, as the legal representative takes on the position of the sponsor with regard to civil and criminal liability and forms a point-of-contact for the EU regulatory authorities, it is important that the company performing this duty understands their liabilities and responsibility for the study. As a specialist provider of legal representative services, IDEA Regulatory recognises the extent of our responsibility and ensures our staff are trained in clinical trial processes and legislation, and the EU regulatory environment.

Many sponsors prefer to use the same provider for all of their studies for consistency and easy vendor management. However, using different representatives for different studies is allowed. According to the Regulations:

• only one legal representative is permitted per sponsor per trial
• multiple trials conducted by one sponsor in the EU may have more than one legal representative
• it is acceptable for a sponsor to have one central legal representative in the EU for all its trials

• IDEA Regulatory are an independent legal entity, meaning we are not connected to any potential competitors and have no conflicts of interest.
• IDEA Regulatory specialise in legal representation as a standalone service so we fully understand the legal implications and requirements, and pass this on in the form of high quality customer service. We strive to ensure documents required from us are never on your critical path.
• Using IDEA Regulatory as opposed to a ‘full-service’ CRO gives the Sponsor freedom to switch to another CRO (for example, when the selected CRO are not performing as desired) while maintaining the same legal representative, thus, avoiding unnecessary complications and paperwork.
• Unlike a CRO, who may be managing several of your other clinical trial services, IDEA Regulatory can offer completely neutral and independent advice.
• We monitor your regulatory deadlines and will give you an extra bit of notice when an Annual Report or update is due, helping you to stay compliant.
• IDEA Regulatory strive to keep our clients up to date on the changing regulatory environment, ensuring compliance is met; to this end we regularly send out newsletters summarising
• any significant new legislation and guidance that has been issued. We publish these here on the website News

Setting up legal representation for a sponsor (i.e. time from approval of cost proposal to receiving fully executed MSA/work order) varies greatly depending on the bureaucratic systems of the sponsor but could feasibly be turned around by IDEA Regulatory (MSA generated, approved, signed and sent to Sponsor) in under a week, providing no major changes to the contract are requested.

Would a confidentiality agreement between a CRO and IDEA Regulatory cover the exchange of information from the CRO’s client?

We have formed suitable CDAs with our regular CRO’s to protect the confidentiality of their prospective and existing clients so that no time is wasted obtaining additional CDAs.

If you are still not sure please ask your IDEA Regulatory Executive.

No. For legal reasons the contract for Legal Representation must be made directly between the sponsor and I.D.E.A. This also enables us to have a more direct relationship with you so we can ensure we can react to your needs.

As Legal Representation is a specific legal requirement, our standard Master Service Agreement (MSA) and Work Order templates contain some very specific legal text. Thus, we prefer to use our own templates to provide a fast and efficient contract review. If using the sponsor’s standard vendor agreement this will require an extensive legal review and our specific text will need to be added, extra time will be needed for this legal review.

IDEA Regulatory legal representation is applicable to all 28 EU member states, these currently include:

Since 1952

• Belgium
• France
• Germany
• Italy
• Luxembourg
• Netherlands

Since 1973

• United Kingdom
• Ireland
• Denmark

Since 1981

• Greece

Since 1986

• Portugal
• Spain

Since 1995

• Austria
• Finland
• Sweden

Since 2004

• Cyprus
• Czech Republic
• Estonia
• Hungary
• Latvia
• Lithuania
• Malta
• Poland
• Slovakia
• Slovenia

Since 2007

• Bulgaria
• Romania

Since 2013

• Croatia

Correct as of October 2013, detailed information and information on Candidate EU countries can be found here europa.eu/about-eu/countries/

No. A legal representative is not required in each Member State. If a multi-centre study is being performed then one European based office is sufficient.

For any country that is not part of the EU no requirements for local legal representatives are applicable by way of the Clinical Trials Directive. There may however be local laws or regulations that apply.

IDEA Regulatory does not have an office in Switzerland and as such are unable to offer this service. We do have a contact in Switzerland and can refer clients to them for local representative.

To enable us to carry out our duties as legal representative and give oversight of your trial IDEA Regulatory requires that the sponsor keep us informed of all of its regulatory, ethics committee, safety and QA activities related to the study, providing updates and amendments as applicable throughout the duration of the trial. These documents include

• Clinical Trial Protocol
• Investigators Brochure
• Patient Information Sheets and Informed Consent Forms
• CTA and EC submissions, amendments and approvals
• List of investigators and sites to be used
• Study Timelines
• Sponsors SOP index/list
• List of planned internal, supplier and site audits
• Clinical Trial Insurance policies (for each Member State)
• Drug Safety Update Reports (DSURs)
• SUSAR Reports
• GCP Serious Breach Notifications (as submitted to the UK MHRA) and any non-regulatory potential investigator fraud investigations

IDEA Regulatory will provide the Sponsor with following documentation and provide updates and amendments as applicable throughout the duration of the Study:

• Signed original copies of a Legal Representative Declaration Letters (as required for submission to most EU CAs and ECs)
• Proof of EudraVigilance registration (if obtained by IDEA Regulatory on behalf of the Client)
• Original copies of any Study related correspondence with CAs & ECs
• Any other original documentation received or generated by IDEA Regulatory that is required by the Sponsor for regulatory or EC submissions or the Trial Master File (TMF).

On the EudraCT Application form the Sponsor is listed in section B.1, the Legal Representative in B.2 and the Applicant in C.1.

All Competent Authorities and Ethics Committees are notified of the legal representatives contact details and are free to contact them at any time should they require information on the trial. However, this would usually only occur if the sponsor has not responded to a request within the timelines set.

The EMA and Ethics Committees in some Member States will copy the legal representative on all correspondence sent to the sponsor. Sponsor inspection notifications are often sent to the legal representative too.

Competent Authorities and Ethics Committees will normally contact the named ‘Applicant’ for information, before contacting the legal representative.

IDEA Regulatory can directly provide regulatory affairs services including:

• Expert advice on EU regulatory issues
• Orphan Drug Designation advice and submissions handling
• Preparation and submission of CTA applications and amendments to EC and CA
• Assistance with sourcing local insurance for patients and healthy volunteers and product liability cover
• Scientific Advice assistance
• Coordinating site inspections with the local authorities

Through our wide network of contacts we can also offer advice and recommendations for clinical trial service providers including full-service CRO’s, Phase I units, non-clinical advisors and facilities, medical device experts, pharmacovigilance specialists, medical writers, monitoring services, clinical trial supply, import and distribution, quality management and auditing services (GCP, GLP, GPvP and GMP), analytical services, central laboratories, HTA experts, and IP and funding resources.

Please email your query to: info@IDEARegulatory.com

or

Telephone: +44 (0) 203 402 3361