Southern Star Research Logo

Safety & Medical Monitoring Services

Ensure a rapid, professional response to any safety issues that arise.

Safety and Medical Monitoring

Expert Safety and Medical Monitoring Solutions

We provide a full range of safety and medical monitoring services to complement or supplement your internal capabilities. Our safety officers and medical monitors have both an in-depth knowledge of medical research and trials, and the commercial insight and experience to identify the safety signals that may impact your product’s viability early in the process.

With their support and guidance, you can rest assured that any serious adverse events in your clinical trial will be identified quickly and managed professionally, and that your final safety review will be a true representation of your product’s viability.

Our Safety Reporting Services Include:

  • Serious Adverse Event (SAE)/Serious Adverse Device Effect (SADE) initial receipt, follow up, review and narrative development
  • Medical coding of terms and concomitant medications
  • Production of CIOMS and/or MedWatch forms for submission to the relevant regulatory authorities and ethics committees
  • Reporting of SAEs, SADEs, Suspected Unexpected Serious Adverse Reactions (SUSARs), Unanticipated Serious Adverse Device Effect (USADE) as per timeline requirements
cells
Safety and Medical Monitoring

Our Medical Monitoring Services Include:

  • 24/7 medical monitoring coverage
  • Protocol review and concept review
  • Patient eligibility review
  • Endpoint adjudication
  • Data Safety Monitoring Committee and Safety Review Committee participation
  • Serious Adverse Event (SAE) review
  • Writing event narratives for submission
  • Medical coding review
  • General medical assistance to study sites and study team on medical queries throughout the study

What our clients say

“As you know we have wrapped up the project, and I wanted to let you know that our internal PM, had really great things to say about your team at the wrap up of the study, especially your PM. Thank you for your commitment to the project and your help with the client over the years.”

Vice President

US based CRO (Pancreatic Cancer)

“I just wanted to touch base to sing praises about your wonderful CRA, now we have handed over responsibilities for the trial. They are such a pleasure to work with! We are really going to miss having them on our team. He has the most lovely manner of working and is flexible, positive, organised and we have loved having him on board with us”

Global Clinical Trials Manager

Australian Pharmaceuticals (Urology)

“Thank you all for doing a lot of preparatory works during SSU period, let us keep up our good work and effective communication so as to let a high-quality study delivered. Thanks again!”

Clinical Operations Manager

Chinese Biotech (Healthy Volunteer)

“I just wanted to say Thank you for a fantastic job you do with our SAEs and staying on top of everything. It is a real pleasure to work with you and I appreciate all you do to support our study.You do a fantastic job!!”

Head, Clinical Operations

US Biotech (Epilepsy)

“I would also like to thank you and your colleagues very much for your dedicated and thorough work on this issue and that I am appreciating very much to work with all of you on the other side of the earth i.e.: Down Under!;-) !”

Vice President, Head of Clinical Pharmacology

Swiss Pharmaceutical company (Diabetes)

“On behalf of the Clinical Team I would like to thank-you for your wonderful assistance with our ethics application and also soon to be submitted, our SSA forms. Your assistance has really helped our team and enabled us to keep on track to submit according to our internal deadlines. Thank-you for all your advice, reviews and creation of documents.We look forward to working with you again.”

Clinical Development Medical Physicist

Australian Biotech (Oncology)

“Your CRAS are top notch and I would work with Southern Star Research any opportunity I could get! Thank you. I know this program was a head banging experience for the team, and they handled it all beautifully.”

Project Director, Clinical Operations

US CRO (Oncology)

Contact us

a man wearing glasses and smiling at camera
Head Office:

L1, 1 Merriwa Street,

Gordon, NSW, 2072 Australia

Connect with us

Sign up to our newsletter

Keep up to date with the latest news, updates and promotions

Copyright 2024 Southern Star Research Pty Ltd

Privacy Policy Legal Notice
icon of a head

Specialist experience

Each member of our Leadership Team boasts an average of 30 years experience. Our clients have access to an extraordinary group of Clinical Research professionals, whose experience covers Multinational Pharmaceutical companies, Biotechnology, Medical Device, CRO’s, research institutes, Universities, Industry Associations & Government Bodies. Together, we ensure that every aspect of your unique and novel drug study  clinical trial is handled with scientific precision, care, and foresight.

Our team has all of the tools, knowledge and experience to solve almost any issue that may arise during the complex clinical trial process.

We recognize that each study is unique and different and there are nuances that need to be resolved proactively.

Our advisory board of top-tier specialists in multiple therapeutic areas engage in the early stages from protocol design in constructive discussions to anticipate challenges and enhance study efficiency throughout the study.