Over the two days, delegates will discuss issues which affect their business and look for practical solutions. Our dedicated and focused event which brings together over clinical operations executives will be the perfect setting for showcasing what steps the industry is taking to improve processes within clinical supplies and patient centricity as well as which operational challenges are currently causing headaches for trial sponsors. Throughout the two days, delegates will enjoy a dynamic programme of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.
At each virtual event we create a welcoming networking environment and an educational program packed with the latest case studies, techniques and providers to set your trial apart. This is the only event that truly demonstrates how patient involvement gets done throughout the entire medicines development life cycle to drive greater efficiencies in clinical research. The program delves deep into patient involvement ideas, strategies and implementation processes that biopharma can utilize in order to help advance patient participation for better clinical outcomes.
Each session demonstrates the what, where, when and how to co-create solutions with patients and measure the impact of those initiatives. By selecting the right databases, you can vastly deepen your understanding of disease epidemiology and the patient journey.
No other life science conference focuses specifically on this topic while streaming on a proven interactive online platform! International Conference on Clinical Drug Development, Clinical Trial Phases and Technology aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of Clinical Drug Development, Clinical Trial Phases and Technology.
It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Clinical Drug Development, Clinical Trial Phases and Technology.
At the last MAGI conference, participants gathered an average of 10 practical tips to implement in their own organizations. Is a MAGI conference right for you? To find out, click here. If you are a clinical research novice or veteran; with a study sponsor, research site, or CRO; in a corporate, academic or other organization; you will find a coherent and comprehensive program that focuses on your current needs for timely and practical information.
MAGI sessions emphasize practical tips based on real-life examples, with lots of interaction. This event is a must attend in the calendar for those involved in the supply of clinical trials.
This event is aimed at enabling knowledge-sharing, benchmarking and network-building amongst biopharma industry peers. The Meeting brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.
COVID has forced more trials to be conducted virtually, and this has the potential to reveal new innovations and improve the patient experience. But how can we ensure this new age of decentralized trials will bring lasting benefits to clinicians, sponsors, and patients, while also accelerating time-to-market?
Switching to virtual trials requires more than just running standard methods in front of a webcam. Your entire clinical approach must be reconceptualized in order to get the most benefit from a virtual approach.
Lack of industry-wide standards is the biggest barrier to collecting and leveraging patient data; each pharma company or vendor may have their own set of systems or safety tools, and integrating these can be a huge obstacle for your pipeline. We are pleased to announce that we will be going ahead on our brand new online event platform on our new dates of May ! Discover effective strategies for outsourcing clinical trial operations to ensure studies run smoothly and within budget.
The programme will feature a range of speakers from the likes of GlaxoSmithKline, Novartis, Pfizer, BMS any many more, who through a variety of interactive session formats will offer insight on promoting successful collaboration between the clinical trials community.
The programme will feature a range of speakers from the likes of GlaxoSmithKline, AstraZeneca, Pfizer, Shire any many more, who through a variety of interactive session formats will offer insight on promoting successful eClinical and clinical data management.
Selecting the best data management tool can help you conserve time and resources by refocusing your study team around higher value tasks.
The Risk-Based Quality Management Summit helps you establish cross-functional risk-management teams to oversee your clinical trials, cutting down risks and accelerating drug development. This is the only life science industry event to specialize on this topic — streaming your way on a proven interactive online platform!
In its 5th year, PCC Canada offers hard-hitting case studies, robust panel discussions and an esteemed speaking faculty to enhance your knowledge of pharmaceutical compliance concerns. Join us in our efforts to accelerate a BIO-Revolution through global partnerships, collaboration, and thought leadership. Now more than ever, the world is counting on us to come together to advance innovation and discovery.
Through a series of keynote speakers, case studies, panel discussions and practical sessions featuring subject matter experts, attendees will be able to access top notch education, without having to travel!
Divided into two streams looking at Early Virtual Trial Maturity and Advanced Virtual Trial Maturity respectively, this one day conference will feature a number of case studies, panel discussions and interactive sessions focused on making your trial run as smoothly as possible. With over 40 solution providers the conference will be a perfect platform to reconnect with current business partners, meet new vendors and discover which new technologies are being employed to improve your decentralised clinical trials.
This event is a must attend in the calendar for those involved in medical device trials. Bringing together experts from across the country to discuss the latest innovations in technology, regulatory affairs as well as discover new opportunities through adaptive approaches and methods to run successful clinical trials.
Driven by purpose and focused on the future of health, the stakeholders who gather at our Global Annual Meeting advance science and technology for public health impact — today, and for generations to come. Attendees at this conference will learn best practices and actionable strategies for evaluating and implementing eTMF systems, engaging eTMF users, improving clinical data management, and achieving cost savings and workflow efficiencies.
Speakers will address specifics as for small, mid-size and large companies. Take advantage of this opportunity to share best practices and network with thought leaders and decision makers in the life sciences. It will explore the benefits of early planning and engagement with the FDA, as well as looking into case studies on what has and has not been an effective strategy in Rare Disease trials.
Access updates from inspiring keynotes, more than presentations, and 3 days of interactive discussion. We challenge how we want clinical trials to look by and share examples from those who are doing something about it.
We highlight major opportunities to fundamentally change how clinical trials are operationalized going forward. Whether you are interested in debating the long term impacts COVID will have on the future of clinical trials, or you want to get stuck into a discussion on best practices for strong CRO communications and building trust, there is something for everyone.
From policy updates and priorities shared directly from Health Canada, to sessions on international work sharing and partnerships to key regulatory and clinical considerations for drugs and devices, you will have the exclusive opportunity to address the current issues and opportunities in Canada and across the globe. The event will once again offer attendees practical take-aways that they can apply to their own studies.
This Pharmaceutical Sciences Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. Pharmacovigilance and Drug Safety:. The pharmacovigilance is related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products, and it is needed in different stages of product life cycle, and the safety surveillance and risk management.
Information received from patients and healthcare providers via pharmacovigilance agreements, plays a critical role in providing the data necessary for Pharmacovigilance to take place, in order to market or to test a pharmaceutical product, adverse event data must be submitted to the local drug regulatory authority.
Finally pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients by safety surveillance and risk management.
Pharmaceutical engineering deals with Pharmaceutical Science and technology that involves development and manufacturing of products, processes, and components in the Pharmaceuticals industry i. While developing Pharmaceutical products involves many interrelated disciplines e.
Clinical Operations have a lot of interaction with people in a range of other departments including Clinical Science , Clinical Quality Assurance, Data Management, Biostatistics and Regulatory Affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful.
The Clinical Operations function of a company is key to the delivery of clinical trials. Without this team no Clinical Research activity could be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I — IV clinical trials.
Many larger pharmaceutical companies have also looked at setting up strategic partnerships with Clinical Research Organizations to outsource some or all of their Clinical Operations activities. Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions. Enrollment Planning and Patient Recruitment:. Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings.
In order to optimize both, you have to have a plan and it should take into account all stakeholders from senior management at the sponsor company and the CRO partners, to the sites and investigators and study volunteers. Patient-Centric Clinical Trials:. Generally accepted principles suggest that patient involvement should extend well beyond consideration as research subjects.
Patient-centric drug development also offers a huge opportunity to define meaningful outcomes from the patient perspective, as a way to ensure the needs and priorities of patient populations are reflected in research. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products.
It's important, therefore, that people make their decision to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved. Innovations in clinical study designs:. Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings.
Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
There are several types of cancer clinical trials, including treatment trials, prevention trials , screening trials, and supportive and palliative care trials. Each type of trial is designed to answer different research questions and will help researchers learn things that will help people in the future. Clinical Trials on different Diseases:.
Clinical Trials for different diseases and disorders are conducted for evaluating one or more interventions for example, drugs, medical devices , approaches to surgery or radiation therapy for treating a disease, syndrome, or condition and also finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches. And Clinical Trials on behaviors, mental, sleep and eating disorders. Medical Imaging in Clinical Research:.
Medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Discover new technologies in medical imaging, and how to implement them in your clinical research.
As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. Clinical Data Management and Analytics:. Clinical data management is the process of collection, cleaning, integration and management of subject data in compliance with regulatory standards. It is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials, this has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies.
CDM also supports the conduct, management and analysis of studies across the spectrum of clinical research. The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics. Future of Clinical Trials and Technology Innovations:. Clinical study design comprises the quantity of study volunteers, their segmentation based on varying factors, and their treatment throughout the clinical trial process.
Study design is a key component of clinical trials , and the treatment of all patients directly impacts the statistical validity of data. Study group assignment has also been comprehensively improved in recent years.
Researchers have found many benefits to randomized assignment versus observational assignment, based on characteristics like gender, age, race, etc. The randomized method has been found to yield more reliable results than observational study assignments. In recent years, the use of Adaptive design methods in clinical research has become increasingly popular due to its flexibility and efficiency.
Adaptive designs offer the potential to reduce study duration and patient exposure whilst maximizing the probability of a successful outcome. Another innovation in clinical trials is the Bucket design. Bucket trials are designed to utilize one particular drug and test that drug against a number of different diseases.
The advantage of this approach is that patients with different diseases can be 'pooled' together under one larger trial instead of lots of smaller trials, thereby saving time and resource in a similar approach, and there are more innovations in clinical trials. Learning from this, some pharma companies have partnered with services such as Lyft and Uber to transport patients to and from trial sites.
Considering that 75 percent of clinical trials will be outsourced by , sponsors and their partners need to work well together. There are a few focus areas to make this succeed, notes executive marketing professional Craig Morgan.
Certainly sharing a vision and goals will foster positive relationships as will a co-authored risk assessment plan and jointly determining KPIs is vital as this allows each party to know what is expected of them and how certain achievements will be measured and appraised.
Morgan also advises that teams should create an atmosphere in which the sponsor and CRO staff act as a single unit functioning together and collaborating on aspects such as protocol design, monitoring strategies and data management. Developing the best type of outsourcing partnership depends on the needs of the sponsor organization. However, most partnerships fall under one of two dominant types, explains regulatory affairs professional Mo Dezfuli.
These are preferred provider or strategic alliance. In a provider alliance, the contractor and provider agree that the latter will perform certain tasks and the former will pay a fixed fee and be solely responsible for drug development. The strategic alliance is more collaborative as the term suggests, and will have the sponsor place greater reliance on the expertise of the CRO.
A greater number of complex tasks will be performed by the CRO and both parties will share collective business goals. Dezfuli says common complaints from CROs include frustration over inadequate communication from sponsors, ill-defined processes, being micromanaged and being left out of the early planning phases.
Of course, outsourcing is a mutual agreement and sponsors can suffer from errors made by the CROs. Not adhering to timelines or failing to maintain quality standards are issues sponsors sometimes have to face. A mistake some pharma companies make, especially in their first outsourced project, is not using the CRO partner to its full capabilities.
The pair advises sponsors to avoid duplication by ensuring the operational team is aware of the big picture as well as any changes that arise.
Of course, a change management plan is key and it needs to be clearly communicated. The state of outsourcing is as strong as it is because many pharma companies are wholly reliant on the services of CROs. Developed markets carry serious cost and efficiency burdens as well as the unpredictability of substances being banned from the market.
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