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Organisation Description

Siara is a highly specialized and focused organisation offering consultancy, training and development in all aspects of ICH GCP and related guidelines. The strategies and solutions that are offered by Siara are visionary, dynamic, practically focused, and delivered by highly experienced and skilled Siara Consultants. Siara offers a comprehensive portfolio of workshops for building the knowledge and technical expertise that is required of clinical research professionals in order to conduct and deliver on good quality clinical research to internationally accepted ethical standards.

Based upon the role an individual plays within clinical research, Siara proposes customized solutions to ensure that the expectations of the roles and responsibilities are fully understood and ultimately implemented in the day-to-day running of a clinical trial. Siara offers solutions at the Sponsor and Investigative Site level.

CPD Courses and Workshops Available

  • Protection of Human Subjects – Informed Consent and the Patient

    Training Course | Siara

    Siara

    This 1 Day workshop will discuss the history of informed consent; the development of the informed consent form and the informed consent process. The key issues in informed consent will be discussed and the roles of the Legally Acceptable Representative and Impartial Witness will be addressed. The dilemmas and issues in consenting vulnerable subjects will be discussed in detail. Current inspection findings will be presented. This is a very practical workshop incorporating role-play; problem scenarios and videos. The documentation expected to demonstrate compliance to the informed consent process will also be described in detail.

  • Ethics Committees in Clinical Research

    Training Course | Siara

    Siara

    This 1.5 day workshop will provide an in depth understanding of the expectations from an IEC in term of processes and procedures as set by ICH GCP. Through case studies; delegates will be able to provide an ethical review of clinical research scenarios. Guidance will be provided on the SOPs and working practices that need to be established to ensure the IEC is in compliance with ICH GCP. This workshop will set the strong foundations in understanding the ICH GCP requirements for IECs and enable the IEC to efficiently establish and implement their working procedures.

  • Clinical Research: Principles of Good Clinical Practice

    Training Course | Siara

    Siara

    This workshop would set the foundations on understanding the requirements of ICH GCP and on how to successfully conduct a clinical trial; ensuring the safety; rights; well-being of the trial subjects are protected and the data that is produced from the clinical trial is complete accurate and unbiased.

  • Good Clinical Practice (GCP) Refresher Workshop

    Training Course | Siara

    Siara

    This 1-day workshop will provide the necessary on-going education in GCP to meet the increasing demands by regulators for a highly skilled and trained workforce. This training will ensure that the delegates understand the expectations set within ICH GCP E6 (R2) and how they should be implemented and the standards maintained. Delegates will be provided with an array of challenging clinical research scenarios across a range of subject matters; allowing them to draw on their knowledge of GCP; external regulations/guidelines as well as their practical experiences to provide effective solutions to day-to-day issues in accordance with Good Clinical Practice.

  • Being an Investigator: Taking the Lead

    Training Course | Siara

    Siara

    This 1 day workshop is specifically targeted towards Sub-Investigators taking on an Investigator role; newly appointed Investigators or Sub Investigators being developed for an Investigator role. The expectations of the Investigator role as per ICH GCP will clearly be defined. Through a series of practical exercises; delegates will understand how the investigators should manage and deliver the clinical study in a timely manner and with quality; ensuring the rights; safety well-being of clinical trial subjects is protected and data produced from the clinical trial is complete accurate and unbiased.

  • Delivering a Successful Clinical Study: A Roadmap for Study Coordinators (SCs)

    Workshop | Siara

    Siara

    This workshop will address the key fundamentals of managing a clinical study at the site.  The SCs will be taken through the life cycle of a clinical study at the site and how to drive success of the clinical study.  Topics will include:  preparing for site selection visits; managing budgets; developing recruiting and retention plans; ensuring site study teams adhere to protocol requirements; delivering quality in clinical trials; proactively identifying and managing risks that may arise in the clinical study.

  • Project Management for Clinical Research

    Workshop | Siara

    Siara

    With the urgency to deliver on good clinical trials faster and with quality; the need for strong project management skills is greater than ever. This workshop will provide the project management skills required to successfully manage clinical trials. Through interactive exercises and scenarios; delegates will learn how to manage and direct clinical their clinical trials rather than simply tracking their progress. This workshop will provide practical guidance on the project management skills employed by clinical research professionals.