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An Innovative Approach in collecting Protocol Deviations for Clinical Trials using EDC



An Innovative Approach in Collecting Protocol Deviations for Clinical Trials using EDC


February 12, 2020 

OVERVIEW 

In this webinar we will explore using EDC as a system to capture protocol deviations in near real time and discuss the benefits of trend analysis across global sites in oncology trials.

The webinar will also provide information on current industry practices, regulatory requirements and benefits of using real time protocol deviation reporting versus traditional methods.

WHAT YOU'LL LEARN 

  • Awareness impact of Protocol Deviation on regulatory submission, subject safety and trial budgets.
  • Understanding of current industry practices and the challenges in reporting protocol deviations.
  • Explore utilizations of EDC system and techniques of collect Protocol Deviations.
  • Trend analysis and KPIs.

WHO SHOULD ATTEND

Intermediate
Advance
Academic Research
Clinical Data Managers
Clinical Database Programmers
Clinical Database Administrators
Other Clinical Research Professionals

WHAT ARE THE BENEFITS 

Learn techniques to optimize the process of collecting PDs using EDC platform.
Standardize the process across a disease portfolio to reduce analysis time, evaluate site performance and increase patient safety.

MEET THE PRESENTER

Loona Borgohain, 

Associate Director, Clinical Data Management.

Loona Borgohain has 15 years of experience working in the pharmaceutical and CRO industry. Loona is passionate about developing and implementing innovative techniques in collecting and analyzing clinical research data. Her goal is to bring us closer to making lifesaving drugs available to patients faster and in a more compliant manner.

She has a deep-rooted commitment to applying her knowledge and experience, to make meaningful difference in patients’ lives and fundamentally change the way cancer and rare genetic diseases are treated. She challenges herself to think big and welcomes different perspectives and backgrounds.

Loona is currently the Associate Director at Agios, a Biopharmaceutical company focused on developing breakthrough medicines for patients with cancer and rare genetic diseases.

EARN CEUs

Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.

WEBINAR REGISTRATION

Registration Member Non-member
Individual $360 $420
Group (max. 10 ppl.) $960 $1,140

Group Registration Policy:
Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.

Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.



Need Support?
Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues.
Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.
General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87