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One of the biggest challenges facing trail sponsors is finding investigator teams with people with the right skills and expertise.
PharmaConsult’s in-house training and mentoring is designed to provide individuals and groups with the essential knowledge and skills in good clinical practice (GCP) to be able to conduct a clinical trial.
The company prepares cost-effective training solutions based on accurately identified requirements, and commissions and manages them through each step of the training process.
PharmaConsult will assist in the preparation of all essential trail documentation, including:
- Protocols, informed consent documents, trial master files, clinical study reports and standard operating procedures
- Evaluation, review, setting-up and implementing quality management (QM) systems in client companies, including writing or support with writing standard operating procedures (SOP)
- Independent full or partial QM or quality assurance (QA) coverage of client companies who need additional resources in QM/QA
- Definition and execution of QM and auditing plans for clinical studies
Regulatory GCP Compliance auditing
PharmaConsult’s scope of services includes audits and inspection readiness assessments of companies, investigational sites, institutional review boards, and documents in different areas of pre-clinical and clinical research.
The company has also been involved in clients’ strategic or business development activities such as due diligence programmes prior to merger and acquisition (M&A) decisions, internal audits and SOP writing activities.
Audits follow the standards of International Organization of Standardization (ISO) 19011 and the ENGAGE Optional Guideline for Compliance and Quality Systems Auditing from the European Network of GCP auditors and other GCP experts. Inspections are conducted to standards of the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
Pharmacovigilance regulatory governance
Pharmacovigilance is a process involving the detection, assessment, understanding and prevention of adverse events, ensuring that medicines are used in the full knowledge of risks. Patients, health professionals, pharmaceutical companies and medicines regulators all contribute to pharmacovigilance activity.
Knowledge acquired from the activity is used to continually reassess the balance between benefits and harms of medicines and for optimising drug therapy in the individual.
By maintaining vigilance for unwanted effects of medicines and by reporting them, clinicians play an important role in establishing a drug’s adverse-effect profile. Spontaneous reporting of suspected adverse effects (Yellow Card reports in the UK), together with post-authorisation (post-marketing) safety studies and literature reports, which all contribute to the knowledge on adverse effects of medicines.
PharmaConsult will provide help in accessing up-to-date sources of information on adverse effects in order to select a medicine and to prescribe it in a way that minimises the risk of harm. Anticipating and minimising adverse reactions to medicines can have a very substantial effect on morbidity, hospitalisation, and on mortality.
Good vigilance practice (GVP) compliance auditing
PharmaConsult audits the pharmacovigilance management system and provides observations on compliance with GVP regulations to prepare organisations for a regulatory authority inspection.
GVP compliance audits comprise:
- The collection and management of data on the safety of medicines
- Looking at the data to detect any new or changing safety issue
- Evaluating the data and making decisions with regard to safety issues
- Acting to protect public health, including regulatory action
- Communicating with stakeholders
- Auditing both of the outcomes of action taken and of the key processes involved
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