Protocol Development (drug and medical devices), Informed Consent Forms (ICFs) and other supporting patient facing information
- We can assist you in the development of a comprehensive, quality protocol or clinical investigation plan in preparation for your clinical trial submission.
- We develop age specific master informed consent documents, along with country specific documents, to support all trial applications.
- We are able to facilitate translations of key, essential documents
- All PHARMExcel produced documents undergo rigorous quality control checks prior to submission to any external authority.
Clinical Trial Authorisation (CTA) submissions and Ethics/Institutional Review Board (EC/IRB) submissions
Our project/study managers (PM), with input from our regulatory advisors, will work with you to collate the submission packages. Our PMs and regulatory advisors know their territory and can brief you on country-specific regulatory and ethics requirements.
Management of Regulatory and Ethics Approvals (including annual reports, progress reports and end of trial notifications)
Our project/study managers (PM), will also manage all ongoing submission requirements, including protocol amendments, progress reports and end of trial notifications.
Clinical Project/ Study Management
- Our project/study managers (PM), are experts in ensuring project delivery for all study types. We utilise bespoke PM tools to ensure your project is driven to meet targets set at the study outset. A dedicated project/study manager with proven expertise in your specialty, will work with you to develop a comprehensive project plan and provide realistic timelines for project delivery. This also allows early identification of any issues that may arise during the course of a study and the ability to provide expedited solutions to keep the study on track. Every stage of your project is carefully managed to ensure it is executed to the highest standards. Innovative, real time reporting throughout the life of the study, gives you a clear perspective of where you’re at – and where you should be – so that any immediate action can be taken.
- Comprehensive communication is utilised throughout all phases of the clinical trial, to build and maintain successful partnerships with our clients and sites. This is following the communication plans that are developed and implemented within the study.
Site Identification and Qualification
Our project/study managers (PMs), and Clinical Research Associates (CRAs) will assist your organisation in identifying appropriate sites and will carry out comprehensive site feasibility and selection, ensuring only the favourable sites are included for your study.
Clinical Monitoring (using risk-based approaches)
We offer a monitoring service for trials of medicinal products, devices and non -regulated studies. Our skilled and well-trained monitors (in house and external) ensure the highest quality review of data and effective interaction with study sites is undertaken. All have experience of working with multiple EDC platforms. We work closely with the study teams to ensure the protocol and applicable regulations/standards/guidelines are adhered to, patient safety and well-being is maintained, and the data collected is credible. Our experienced CRAs will develop a robust monitoring plan based upon the risk of the intervention and the known, inherent risks of the study procedures.
Clinical Trial Pharmacovigilance
We work with you to support the safety management aspects for your trial from assisting you with developing the safety sections of your protocol/clinical investigation plan through to processing of serious adverse events/serious adverse device events (SAEs/SADEs) and expedited reporting of unexpected serious adverse drug/device reactions (SUSARs/USADEs) to the regulatory authorities, ethics committees and investigators. We also have the capabilities to develop robust and applicable safety monitoring plans and manage the set up (and attendance if required) of independent drug safety monitoring committees (IDMCs).
Trial Master File Management
For most of our studies we hold the Trial Master File (TMF) and our Clinical Trial Assistants (CTAs) are responsible for ensuring all essential documentation is maintained throughout the lifecycle of the trial. At the end of the trial we can either return the TMF to you in your required format or archive the TMF against your required specifications.
Biostatistics/Data Management (including EDC provision)
We work with highly experienced data management vendors who can provide both statistical support for all phases of studies and a comprehensive EDC system. The electronic data capture software is fully 21 CFR Part 11 compliant. Full control is provided to assign which users can access, sign and modify forms. It also supports multi-arm and stratified randomisations.
We have the appropriate skills to develop essential trial documents that will meet the regulatory requirements. This includes protocols, development safety update reports and clinical study reports.
Clinical Quality and Compliance
In the current clinical trial environment, there is a large emphasis on organisations to have the infrastructure and framework to ensure their clinical trials are compliant with current regulations. PHARMExcel place quality at the top of their agenda and ensure it is embedded in all we do. We have a compliant Quality Management System (QMS) that is aligned to ISO 9001 standards and with international and national regulations. Our Quality Assurance (QA) consultants are well versed in local, national and international regulations, standards and guidelines and oversee our internal quality audits.
We ensure a Quality Management Plan (QMP) is produced for all our studies. So, you can be assured your study is conducted to the highest standards.
We can provide CQA services to help our clients and sites develop the most effective methods for correcting and preventing any nonconformity.
Among the CQA audits we conduct are:
- Clinical investigator site audits (routine, directed and pre-inspection audits to help sites prepare for regulatory inspections)
- Clinical study document reviews (Trial Master File and Site File)
- System audits, in which we assess a client’s standard operating procedures (SOPs) and processes and recommend improvements where needed.
- Vendor audits, in which auditors evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations
Finally, we can be there to help you through Regulatory Inspections, from preparation and supporting through to the inspection days and assistance in forming responses and Corrective and Preventative Actions plans (CAPAs).