Objective
Compliance and Quality: All Shire sponsored trials are conducted under GXP standards and adhere to the ethical principles of the Declaration of Helsinki. SOPs, policies and standards are implemented and enforced in accordance with ICH guidelines as well as any other applicable regulations. All personnel and investigators are trained according to the appropriate Shire and GXP standards.
Safety: Highest standards of safety monitoring and reporting are applied for the protection of the subjects and patients enrolled in clinical studies and patients using marketed products: Shire protocols contain standard approved safety reporting language and are subject to a strict risk/benefit assessment by our physicians and submitted for approval to an Ethical Committee review. Safety Review Teams proactively monitor clinical trial safety data as well as review relevant data prior to major milestones such as first time given to humans and prior to obtaining authorization to market. Safety signal detection processes are applied to post-marketing spontaneous report data.
Patient Information: Patients and subjects are informed about the principles and potential risks of the trials: Informed Consent as defined in GCP is obtained and documented for all patients/subjects included in our trials.
Risk Management: Effective risk management practices during the post-marketing period assess risks to patients and minimize risks utilizing high quality educational and outreach programs aimed at patients and healthcare providers: Risk management strategies are developed prior to launch, and implemented and monitored during the post-marketing period.
Medical Information: A clearly identifiable resource is available to manage all medical, pharmaceutical and technical enquiries on Shire products to support their safe and effective use in treating patients: The Medical Communication function provides scientifically based and balanced information on the Shire product portfolio to enable Shire customers to make informed decisions when treating patients. Guidelines and SOPs are established to streamline the creation and maintenance of the medical information knowledge base and the training of the information professionals providing this information.
Animal Testing: Minimize animal use and ensure high standards of animal care by; Use alternatives where available and scientifically justifiable. Use only vendors that have ethical review process and quality animal welfare procedures.