International Drug Discovery & Clinical Research

08/01/2025

The U.S. Food and Drug Administration (FDA) has taken a significant step in regulating the use of artificial intelligence (AI) in drug and biological product development by issuing its first draft guidance on the topic. This guidance provides recommendations for using AI to support regulatory decisi...

08/01/2025

https://www.iddcrcro.com/post/fda-issues-landmark-draft-guidance-on-ai-use-in-drug-and-biologic-development

The U.S. Food and Drug Administration (FDA) has taken a significant step in regulating the use of artificial intelligence (AI) in drug and biological product development by issuing its first draft guidance on the topic. This guidance provides recommendations for using AI to support regulatory decisi...

31/12/2024

Wishing you a prosperous and fulfilling 2025! May the new year bring new opportunities, growth, and success in all your endeavors. Happy New Year! #2025

24/12/2024

23/09/2024

Clinical data migration from legacy systems to electronic data capture (EDC) systems is a critical process in modern clinical research. It involves transferring patient data and metadata from outdated or inefficient systems to a more advanced EDC platform. This migration is essential for improving data quality, enhancing research efficiency, and ensuring regulatory compliance.

We support for Clinical Data Migration. Please contact us to know more.

https://www.iddcrcro.com/edc-epro

22/09/2024

An investigator-initiated study (IIS) is a research project designed and conducted by independent investigators, often affiliated with academic institutions or research organizations. Investigator-initiated studies play a vital role in advancing scientific knowledge and addressing unmet medical needs. Despite the challenges they face, IIS offer valuable opportunities for researchers to pursue innovative research and contribute to the development of new therapies and interventions.

We support for investigator-initiated study (IIS). Please contact us to know more.
www.iddcrcro.com/iis

28/12/2022

TEN CLINICAL RESEARCH CAREER PATH
--------------------------------------------
Clinical Research is a branch of Life Sciences that investigates the safety and effectiveness of new treatments and the suitability of these treatments for human use. Particularly over the past 18 months, the global Clinical Research market is continuously growing and evolving, with more and more career opportunities becoming available within this vast field.

In 2020, the global Clinical Trials market was estimated at $44.3 billion, and this is expected to grow at an annual rate of 5.7% between 2021 and 2028. The National Institute for Health Research (NIHR) also recorded that between April 2020 and March 2021, 1,390,483 participants took part in Clinical Research across England, which is almost double the numbers from the previous year.

The huge growth in this industry is also evident in the noticeable increase in the number of available career opportunities within Clinical Research. Over the past year, the average number of Clinical Research jobs on PharmiWeb.Jobs has doubled, and this continues to be the discipline with the most available opportunities on our job board.

In this article, we look at 10 different career paths within Clinical Research, with an outline of some of the most common responsibilities for each role…

1. Clinical Trials Manager / Administrator
--------------------------------------------
Clinical Trials Managers / Administrators are responsible for the administrative aspects of clinical trials. Their duties often include:

- Preparing essential documents and ensuring documentation is kept private and confidential.
- Attending safety and study start-up meetings and coordinating investigator meetings.
- Managing clinical trial supplies.
- Reviewing trial protocols and identifying any protocol issues.
- Processing and tracking payments to investigator sites.

2. Clinical Research Associate (CRA)
---------------------------------------
CRAs are responsible for organising and administering clinical trials and are typically involved in all stages of a trial, from identifying investigator sites to closing down the trial. The responsibilities of a CRA can include:

- Identifying suitable facilities to be used as trial sites and selecting an investigator to be responsible for the site.
- Briefing trial investigators and instructing clinicians on how the trial should be conducted.
- Writing up clinical trial methodologies and designing trial materials.
- Monitoring the progress of clinical trials and preparing final reports.
- Designing and authenticating data collection forms and managing regulatory applications/approvals.

3. Clinical Project Manager
-----------------------------
Clinical Project Managers are responsible for managing the workers involved in clinical research projects, ensuring protocol compliance whilst coordinating projects to meet clinical objectives. The main responsibilities of a Clinical Project Manager may include:

- Overseeing the enrolment of subjects into clinical trials by assessing the eligibility of potential subjects and tracking the enrolment status of suitable participants.
- Ensuring compliance with protocols and informing investigators of any protocol issues.
- Monitoring study activities to ensure the study remains on schedule and is kept within allocated budgets.
- Maintaining records of study activity, including records of side effect data.

4. Pharmacovigilance / Drug Safety Officer
-----------------------------------------------
Pharmacovigilance Officers, also known as Drug Safety Officers, are responsible for ensuring that new and existing drugs on the market are safe for patients, and for identifying any issues with these drugs. They may be responsible for:

- Monitoring the effectiveness of new drugs and pharmaceutical products already on the market.
- Monitoring adverse effects to new or existing drugs and flag any early warning signs of these to minimise risk.
- Conducting interviews with patients and healthcare professionals.
- Completing safety update reports and conducting safety audits.

5. Study Start Up Associate
------------------------------
Study Start Up Associates are integral in making sure that clinical research sites are well prepared to begin a new trial. They can be involved in the following:

- Executing start-up activities before site activation including preparing consent forms, identifying new investigator sites, allocating study budgets, and supporting patient recruitment and retention.
- Ensuring physicians working at research sites are prepared to begin trials.
- Obtaining appropriate ethics and regulatory approvals and ensuring research operations comply with protocols.
- Analysing study start-up metrics to ensure efficiency and identifying areas for development, including in terms of start-up timelines.

6. Clinical Research Nurse
----------------------------
Clinical Research Nurses help to improve patient care by supporting patients through their treatment, ensuring they are both safe and fully informed of the study activities. Some of their main responsibilities could include:

- Helping to develop new treatments and care pathways for patients.
- Aiding data collection activities.
- Ensuring patients give full consent prior to being enrolled in clinical trials and making sure patients fully understand all aspects of the study before doing so.
- Assisting the principal investigator with pre-study preparation and study start-up activities, including preparing protocols for regulatory and ethical approval, and attending investigator meetings.
- Arranging appointments for potential and enrolled trial participants.

7. Clinical Research Scientist

Clinical Research Scientists are responsible for undertaking medical research in research labs to find more effective ways of diagnosing and curing a variety of illnesses. They may also be responsible for:

- Interacting with patients taking experimental treatments to understand the effectiveness of these treatments and to investigate new ways of improving their wellbeing.
- Working with other medical staff to advise on how to use products and equipment already on or coming to the market.
- Analysing data to further develop treatments and test any new methods of diagnosis and treatment.

8. Clinical Investigator
------------------------
Clinical Investigators ensure that the investigation is meeting research expectations and is conducted in line with the investigator statement, investigational plan, and all necessary regulations. By doing so, they protect the welfare of clinical trial participants as well as the integrity of the resulting data. Their responsibilities can include:

- Meeting specific guidelines and/or requirements set by applicable regulatory and ethical bodies.
- Conducting or supervising research to ensure the investigational plan and corresponding study protocols are being followed.
- Notifying relevant bodies of any changes in research activity, including any unanticipated obstacles that may introduce risk to study participants.
- Ensuring informed consent has been obtained from all participants.
- Maintaining records of the clinical studies and preparing reports to be sent to investigation sponsors and other relevant bodies.

9. Patient Recruitment Specialist
-----------------------------------

Patient Recruitment Specialists are responsible for recruitment-related activities. Their main responsibilities include:

- Recruiting participants in line with protocol-specific inclusion and exclusion criteria.
- Tracking recruitment progress and developing new and existing recruitment strategies.
- Contacting potential participants to assess eligibility and to schedule site visits.
- Ensure patient information is accurately collected and entered into the relevant database and is protected.

10. Biostatistician
-------------------
Biostatisticians provide statistical support to clinical studies and work across all study phases. Typically, their work can include:

- Obtaining clinical data from the Clinical Data Manager to undertake necessary statistical analyses. Interpreting the meanings of statistical outputs resulting from different analyses.
- Assisting the Clinical Trial Manager in writing up the final technical paper for the study, sharing findings from statistical analyses.
- Analysing safety and efficacy data and applying statistical methods to develop the science of data analysis.

Clinical Research is a desirable career option due to competitive salaries, opportunities to travel and good levels of future job security. Work in Clinical Research can be challenging, but it can also be extremely rewarding and varied, and the industry is constantly evolving.-

28/12/2022

8 Reasons to Choose a Career in Clinical Research

The global clinical trials market size is predicted to hit $84.43 billion by 2030, up from $48.4 billion in 2020. A huge amount of talent is needed to drive this growth, and Clinical Research Organisations (CROs) are having to work harder than ever to engage and retain this talent in a job market that remains highly competitive.

As well as an increasing number of opportunities available for jobseekers looking to enter Clinical Research, jobs in this field can be extremely rewarding, albeit challenging. There is huge potential for career development, as well as competitive salaries and job packages on offer for the right candidates.

For those looking for their first entry-level role, and those looking to transition into Clinical Research from a related field, we’ve rounded up 8 benefits of working in Clinical Research and being a part of this booming industry…

1. Make a Real Difference

Working in Clinical Research gives you a unique opportunity to make a real difference to people’s lives. You’ll be working towards not only saving lives but improving the quality of life for people across the globe, and this makes a career in this field extremely rewarding.

Large CROs such as Parexel work across a broad range of therapeutic areas, from infectious diseases to rare and orphan diseases. This allows for ample opportunity to work on a variety of drugs and devices across the industry, making a difference in more areas than one, and serving patients across the board.

2. Expand Your Professional Network

Roles within Clinical Research require a lot of collaboration between different groups of stakeholders, including patients, physicians, researchers, site investigators, ethics committees, and more.

A career within this field will allow you to utilise your scientific expertise whilst also getting you away from laboratories to meet new people at research sites across the country. This provides an excellent opportunity to grow your network beyond your direct colleagues.

3. Enhance Your Learning and Development

There is plenty to learn within this dynamic industry. No two studies you work on will be the same, and with the digitalization of clinical trials expected to accelerate rapidly over the coming years, there will always be a new skill or new technology to conquer.

As Clinical Research is highly collaborative, you’ll have plenty of opportunities to develop both your soft and hard skills, helping you to become a well-rounded professional. Work in Clinical Research is also extremely varied, meaning you’ll develop a broad range of skills through continuous learning.

4. Transition Into the Industry Through an Entry Level or Graduate Career Pathway

CROs such as ICON invest heavily in developing early talent and provide plenty of support to those taking their first steps in the industry. ICON offer plenty of entry level and graduate opportunities, including their CRA Graduate and CRA Bridge programmes. Whether you’re looking for your first ever full-time role or are looking to transition into Clinical Research from a similar field, there is support in place to help you kickstart your Clinical Research career.

5. Discover New Areas

Some roles, such as that of a Clinical Research Associate (CRA), require you to travel between numerous trial sites, sometimes both nationally and internationally. Although you’ll be travelling for work, you may get to do some exploring during your down time. It can be tiring work, but enjoyable for those who don’t want to be in an office full-time.

6. Earn a Competitive Salary and Benefits Package

Starting salaries in Clinical Research can be very competitive, with plenty of room for progression towards high paying roles. Many companies in the industry will also offer a range of healthcare benefits; including things such as private healthcare, dental care, and vision care, saving you money whilst helping you to look after your health.

7. Find Stability and Job Security

Although you can never fully predict what’s around the corner, for the most part, working in Clinical Research provides you with excellent job security. The work of pharmaceutical companies will never stop, especially with technological advances making way for new, innovative treatments to previously thought incurable illnesses. There are still so many illnesses and diseases out there to be cured, and many still yet to be diagnosed.

8. Be Part of a Booming Industry

Countries such as the United Kingdom are investing heavily in the development of their life science industries. In 2021, the UK government announced a 10-year strategy to help the country solve some of the biggest healthcare problems of our generation. As part of this, more funding will be given to running innovative clinical trials to develop breakthrough products and treatments, and to ultimately save more lives across the globe.

After the COVID-19 pandemic, leaders across the globe are eager to do more to protect the health and overall stability of their countries, and greater investment in Clinical Research is set to pay a huge part in this.

Source: PharmiWeb

28/12/2022

July 12, 2022 | Worldwide Clinical Trials and Invitae have announced a strategic partnership. Worldwide will be the first CRO to use Invitae’s Explorer tool, part of its real-world data platform that enables access to aggregated genetic testing results.

Through this partnership, Worldwide has access to data insights based on prevalence, incidence, demographics, geography, and epidemiology for rare disease patients. This aggregated data enables Worldwide to recruit patients faster and pinpoint optimal study locations to help its sponsors uncover new and potentially life-saving treatments for people suffering from rare diseases.

“This is a game-changer for both our sponsors and patients enrolled in clinical trials,” said Peter Benton, President and Co-CEO, Worldwide, in a press release. “Our unique access to Invitae’s database provides us with superior visibility to an aggregate-level view of patients we otherwise wouldn’t be aware of and enables us to offer advanced clinical trial strategies to our sponsors. This also helps us boost much-needed patient recruitment efforts, expanding our reach and ability to connect the right patients with the right clinical trial opportunities.”

“Our strategic collaboration enables Worldwide to gain valuable insight into the genetic etiology of rare disease to help shape and improve the future of clinical trials,” said Sean George, Ph.D., Co-Founder and CEO of Invitae in the same press release. “Our cutting-edge tools empower Worldwide with the opportunity to set clinical trial strategies based on specific disease and geographic prevalence to yield the data needed to treat genetic disorders globally.”

With access to Invitae’s aggregated genetic testing data, Worldwide has enhanced its capability to combat the complexities of rare disease trials through quicker visibility of where patients are, with the ultimate goal of providing well-deserved and meaningful treatments.

Source: Clinical Research News

25/12/2022

MERRY CHRISTMAS