11^th International Conference on Clinical Research & Clinical Trials March 15-16, 2021 Amsterdam, Netherlands

Track 1:  Clinical Trials & Pharmacovigilance

Clinical trials which is a step by step process of phases to achieve the safety and efficacy of a chemical or biological compound. The pharmaceutical company involved in the research and development of a medicinal product and trials are closely monitored by an investigator. The process benefits from autonomous review by Independent Review Boards, Ethics Committees and drug safety firms. Pharmacovigilance fits into this process; that is to be safe and effective products reach patients. Pharmacovigilance deals with the study of understanding and monitoring the adverse effects caused by a drug and assessing, which includes detection of adverse effects based on relevant findings, prevention or minimization of adverse effects.

• Drug’s Safety and Efficacy
• Pre Clinical Research
• Clinical Study Designs

Track 2:  Patient Centric Clinical Trials

Patient Centricity includes initially, patients need ethical and sustained relationship which reflects in how to develop medicines and not treating patients as transient commodities but are an integral and valuable partner in the process. Secondly, patients expect to be treated with respect for who they are and the feedback they give. Credible medical information has been reduced or removed many of the barriers. Physicians and pharmaceutical companies no longer have exclusive access to information regarding diseases and medical conditions enabling even those patients with the highest respect for their physicians to undertake their own layman’s research, supplementing physician-provided information.

• Clinical Development
• Research and Discovery
• Open Communication Channels

Track 3: Adaptive Trial Model

An adaptive clinical trial defines a clinical trial that evaluates a medical device or treatment by observing possibly other measures, such as side-effects on a prescribed schedule, and modification of the parameters of trial protocol in accordance with those observations. Generally, the adaptation process continues throughout the trial, as prescribed in the trial protocol. Modified dosage, sample size, drug undergoing trial, patient selection criteria are included.  Trials become an ongoing process which regularly adds therapies and patient groups as more information is gained.  The trial protocol set before the trial begins and the protocol specifies before the adaptation schedule and processes.

• Estimating treatment effects
• Trial planning
• Maintaining trial conduct and integrity

Track 4: Post-Clinical Trial closed communities

Clinical trials are key for bringing out newer and better drugs to serve the mankind. It is the most expensive and time consuming component of a new drug development process. Currently, scientific era & research is taking a major stride in all streams and newer and better drugs are being introduced to cure ailments, which are difficult to treat. Although the conduct of clinical trials is governed by a set of well-defined guidelines to be followed, it is still looked upon as an area of humanitarian concern at times. As the patients are the key for every clinical research project, the focus of all the clinical research guidelines is towards protecting the rights and following the guidelines, safety and well-being of study subjects.

• Post trial access
• Drug Marketing
• Clinical Trial Diversity

Track 5: Clinical Data Strategy and Analytics

A comprehensive data strategy states only large organizations can afford as it is critical for developing a governed data flow and prioritization strategy. Data strategy helps to focus the organization on the most immediate needs which will deliver the value quickly to end users. As software technology enabled data services provider, eCS clients shared the challenges and data chaos that comes with having numerous CROs and data source providers. A formalized data strategy help with these challenges ensuring organizations and gain control of the data that they are investing tremendous resources in.

• Clinical Data Management
• Automation
• Analytics

Track 6: Clinical Trial Auditing

Independent and methodological review of clinical research activities and documents to determine whether the activities related to the establishment and monitoring of this clinical research were conducted, if the data were collected, analyzed and reported in compliance with the protocol, standardized operating procedures. System audits should be of a reasonable size and easily manageable with the resources provided (can be managed). Audits must be organized and conducted in such a way that they generate in acceptable results. Most importantly, do not downgrade your audit program, leave windows for non programmed audits.

• Pre-study Qualification Visit
• Monitoring of Clinical Trials
• Auditing of Clinical Trials

Track 7: Implementing Risk Based Monitoring

The cost and complexity of clinical trials have grown dramatically in recent years. One third of study's cost can be attributed to the traditional on-site review of trial data. This approach, heavily reliant on exhaustive source data verification, has proven to be not only resource-intensive, but limited in its ability to identify and prevent issues. Efficient monitoring is critical to protect the well-being of trial participants and to maintain the integrity of final results, it is generally accepted that the process for clinical trial monitoring needs to change.

• Data Integrity
• Detection of Critical Data and Processes
• Risk Assessment

Track 8: Oncology Clinical Research

The scope for oncology research is always high, and clinical trial designs, study designs are increasing in complexity. Currently, reports indicate that the success rate of investigational compounds approved for clinical use in cancer is the lowest among all diseases, and the likelihood of approval for oncology drugs got tested in Phase I trials is only 6.7 percent. There are significant variations of clinical trials in oncology. The differences understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.

• Cancer subtypes
• Creation of oncology study data
• Systematic evaluation

Track 9: Imaging Research

Medical imaging is the process used to make images of the body parts for medical uses to identify or to study diseases. There are millions of imaging processes done every week around the globe. Medical imaging is developing rapidly due to development in image processing techniques which includes image recognition, analysis, and enhancement. Image processing increases the percentage of tissues identified and also amount of detected tissues. The application of image analysis techniques in this field summarizes how to exemplify image interpretation challenges using different image processing algorithms such as k-means, ROI-based segmentation, and watershed techniques.

• Digital Image Processing
• Medical Imaging Systems
• Image Processing Techniques

Track 10: Post Marketing Surveillance

Post marketing surveillance is monitoring the safety of a pharmaceutical drug and medical device after the release in the market and is a key part of the science of pharmacovigilance. Since drugs and medical devices are accepted and approved on the basis of clinical trials, which involves relatively small numbers of people that they normally do not have other medical conditions which exists in the general population and post marketing surveillance can further refine, or confirm and the safety of a drug or device after it is used in the general population by large numbers of people who have a wide medical conditions.

• Pharmacovigilance
• Marketing Authorization
• Strategy and Drug Research

Clinical preliminaries are significant for finding new medicines for illnesses, just as better approaches to distinguish, analyze, and diminish the opportunity of building up the infection. Clinical preliminaries can show scientists what accomplishes and doesn't work in people that can't be learned in the research facility or in creatures.

The global clinical trials market size was estimated at USD 46.75 billion in 2019 and is anticipated to expand at a CAGR of 5.1 % over the forecast period. Adoption of new technology in clinical trials, increasing prevalence of chronic diseases, and demand from developing countries are some of the major factors driving the global market. Whereas increasing demand for Contract Research Organizations (CROs) to conduct clinical trials is projected to further drive the growth.

The geographical distribution of clinical trials is slowly shifting from developed nations to emerging countries. Rising cost of clinical trials and difficulty in patient recruitment has led biopharmaceutical companies to shift focus on regions such as Central and Eastern Europe, Asia Pacific, Latin America, and Middle East for cost efficiency and quick patient recruitment. Emerging countries also possess greater disease variation compared to west, where traditional diseases are prevalent. The greater disease variation in the developing countries helps biopharmaceutical companies perform clinical trials for rare diseases.

On the basis of phase, the clinical trials market is segmented into phase I, phase II, phase III, and phase IV. Phase III accounted for the largest market share in 2019, as these trials are most expensive and involve huge subjects.

In phase I clinical trials, the investigator spends several months looking at the effects of medication on 20 to 80 people. It also evaluates the tolerability of molecules as the end-point to approve the trial. The other studies such as food and drug to drug interactions are also necessary to performed. According to the FDA, approximately 70% of medications move to phase II.

Phase II trials are performed in two parts; in the first part the range of dose is explored along with efficacy studies while in further study the dose is finalized. In case of oncology, Phase II studies play a crucial role. The FDA estimates that about 33% of medications reach phase III trial.

In Phase III, long term safety studies are performed for registration. In June 2015, Aeterna Zentaris selected Ergomed for its Phase III studies. The U.K. based CRO is likely to help the company conduct the efficacy studies for Macrilen, which is used for adult growth hormone deficiency.

Phase IV studies are also known as post marketing surveillance studies. These are done after the molecule is launched in the market. Initially, the molecule is launched in small number and data is collected to validate its safety for general population.

10th International Conference on Clinical Research & Clinical Trials Webinar on March 18 -19, 2020 was successfully completed with the encouragement and support of speakers during COVID – 19. We are glad to announce 11th International Conference on Clinical Research & Clinical Trials, March 10-11, 2021 which is going to held in Amsterdam, Netherlands.

We were overwhelmed by their generous response.

• Timir Kumar Shah, Divyam Institue of Psychiatry, India
• Nabil Nasr, Associate Provost for Academic Affairs & Director, Malaysia
• F.X. Frapaise, President of the French Association of Pharmaceutical Medicine, Paris
• DonatoBonifazi, Consortium for Biological and Pharmacological Evaluations, Italy
• Jay Smith, Transperfect LifeSciences, USA
• El Hadji Seydou Mbaye, International Agency for Research on Cancer, Senegal

We would like to thank each and every participant of Euro Clinical Trials 2020 webinar to make this a huge success. And special thanks to media partners for the promotion of our event.

Hoping a huge success for next series 11th International Conference on Clinical Research & Clinical Trials Webinar, March 10 - 11, 2021.

1.Meet Experts & Influencers Face to Face

While not all conferences offer you the opportunity to meet your business idols, your chances are greatly improved when you’re sharing the same space. Sometimes it’s about taking a selfie with someone who’s influenced you or sharing a business idea with someone you admire, or making a connection that can lead to finding your next mentor.

2.For people to meet you

This is particularly vital once you are searching for collaborators, job ideas, or in some fields you will even be searching for committee members. Conferences are in our own way to urge your name and you calculate there as you start to ascertain yourself in your field of study, particularly if lucky to be invited as a speaker.

3.To present your ideas and work to others

1.Famous Scientific Professionals in Pharma and Chemistry

2.Personnel (Professors, Associate Professors, Asst. Educators)

3.Pharma and Chemistry Colleges and Training Institutes

4.Drug and Chemistry Associations and Societies

5.Drug Business Entrepreneurs

6.Assembling Pharmaceutical items Companies

7.Assembling Medical Devices Companies

8.Pharma and Chemistry Students

9.PhD Scholars, Graduates and Post Graduates

10.Chiefs, CEO's of Organizations

11.Affiliation, Association presidents and experts

12.Honorable laureates in Health Care and Medicine

13.Bio instruments Professionals

14.Bio-informatics Professionals

15.Examination Institutes and individuals

16.CRO and DATA the executives Companies

17.Information Management Companies