Global Research Regulatory Strategy
The fastest route for clinical trials approval starts well before clinical trials are initiated, to understand both the regulatory landscape (i.e., guidelines, important stakeholders, emerging policies) and relevant precedents.
Regulatory guidance in these areas can help to build a crucial framework for the overall development plan and aid in determining the fastest and/or greatest value path.
With a comprehensive regulatory strategy in hand, sponsors can fully understand the expectations, carefully evaluate potential hurdles and create a plan to proactively address them early.
Clinical Trials Feasibilities
Clinical Trial Feasibility is the best means for predicting the speed at which Investigators will enrol patients and how the data flow will occur over time. Through a comprehensive feasibility mitigate potentials delays and cost implications.
Our feasibility assessment include but are not limited to: investigator and site interest and experience, local associated cost, patient population to determine the speed of enrollment, availability of referral networks, competitive trials, availability of equipment and facilities, impact of study procedures on standard of care and any other study or sponsor requirements.
Our team will work with you to perform a more strategic and productive outcomes to reach faster the green light to move forward.
Eudra CT application
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports).
The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive.
Regulatory Clinical Trials Application
The safety of trial subjects is the core principal under which the assessment of Clinical Trial Authorizations applications is conducted by the Regulatory Agencies.
This is particularly relevant to phase I, where there is no treatment benefit to subjects, but applies throughout clinical development and into phase IV (i.e. Post-marketing) trials.
That guides the regulatory assessment and applies equally to trials involving small molecules and biological/biotechnological products, including Advanced Therapy Medicinal Products (ATMPs). For each trial, subject safety must be balanced against the potential benefits available, so while the assessment principles remain unchanged, the level of risk considered acceptable for a potentially life-saving therapy will be considerably higher than that for a therapy with less radical consequences.
The objective to ensure subject safety is common between sponsor and regulator and the focus is on the ease with which risks to subject safety can be identified and alleviated. Naturally, other factors are taken into account, such as regulatory requirements, and emerging non-clinical and clinical data.
We recommend early dialogue between our expert team, customer, investigators and Regulatory agency (if uncertainties are identified) to avoid unnecessary work and potential delays.
Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) Applications
Understanding the requirements and expectations of the multiple Independent Ethics Committee and/or Institutional Review Boards is crucial for the speed of the approval to initiate the clinical trial.
These independent bodies (a review board or a committee, institutional, regional, national, or supranational), are constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Our expert team advise and produce the most efficient applications to minimize the impact of potential additional clarifications requested by IEC/IRB.
Site Contracts Negotiation
A key factor for a fast success to start a clinical trial on time is the smooth quality site agreement negotiations. Nowadays still is a potential major delaying document. Therefore it is important that the agreement negotiations are organized well to be consistent within a short timeframe.
Our experienced team will assist with managing agreements of hospital, investigator, laboratory, pharmacy, drug depot and other vendor agreements at an international level. Our research library of quality templates and efficient processes for daily tracking allows a smooth process for successful agreements on time.
Investigations Medicinal Products (IMPs) import/export
Our team help to answer a wide range of stakeholder queries, which relate to the manufacture, import, labelling, licensing requirements and general handling of Investigational Medicinal Products (IMPs).
When it comes to drug import-export, the last outcome a sponsor wants is to end up with a detained product. Drug products, and drug components such as active pharmaceutical ingredients (APIs), imported or offered for import into another country must comply with all the applicable requirements and regulations. Support to obtain the certificates for IMPs import-export for different types of drugs and drug products is in our portfolio of services.
Biological Samples import/export
The concern over the safe and secure transport of biological material has intensified in an effort to ensure personal and public safety. Our team request the Permits of competent authorities and advice on transport requirements for Import or Export of Biological Materials must be available to avoid shipment release delays or shipment confiscation and destruction by the Quarantine Officer at the port of entry.
All hazardous material packages shipped internationally are subject to the requirements established by the United Nations International Civil Aviation Organization (ICAO) whose guidelines are adopted by the International Air Transport Association (IATA). Both regulatory bodies establish definitions and requirements for the classification, packaging, marking, labelling, and documentation of hazardous material packages. Personal, civil and criminal penalties have been established for wilful violation of these regulations.
All packages being offered for transport must comply with all international regulations for ground and air transport in order to protect the safety of the laboratory staff, support staff, the environment, and the public.