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Medical Writing

From protocols, CIPs and study designs to final clinical study reports.

Medical Writiing

Comprehensive Medical Writing Services for Clinical Trial Success

Our collaborative and astute team of medical writers can support you in all stages of your clinical trial, from protocols, clinical investigation plans (CIPs) and study designs to final clinical study reports.

With our expertise, data-driven approach and breadth of experience, you can be assured that all your medical writing will be completed to the highest possible standard, setting up your clinical trial and product for future success.

Clinical Trial Protocol Writing

As a CRO early phase specialist, our medical writers are well-equipped for clinical trial protocol writing and review, from First in Human to Phase 3 and beyond. With in-depth knowledge of treatment practices and standards of care, we are experts at writing protocols and CIPs that balance scientific evaluation with on-site practicality, investigator engagement and subject recruitment considerations. We also have established relationships with many therapeutic area leaders who can provide their expert opinion prior to finalization of your protocol or CIP. 

We can assist with:

  • Study design
  • Endpoint development and evaluation
  • Input into pharmacokinetic (PK) and pharmacodynamic (PD) considerations
  • Sample size calculation
  • Medical writing of protocols and case study reports to international standards
  • Statistical analysis and interpretation
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Medical Writiing

Clinical Study Report Writing

Clinical study reports are key to the commercial viability of your product. Our medical writers, in collaboration with our team of expert biostatisticians, can present the results, analysis and interpretation of your study accurately, clearly and concisely, while also guaranteeing that your report meets the content and format requirements of international regulators.

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

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Head Office:

L1, 1 Merriwa Street,

Gordon, NSW, 2072 Australia

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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.