Coronavirus Vaccine Study
US biotech company selected Paratus Clinical to be involved in a Phase 1/2 trial of a COVID-19 vaccine in healthy adults 18-59 years of age.
The ultimate goal of the Sponsor company was to allow rapid advancement during the current coronavirus pandemic.
- Paratus was the first Australian site activated and first to randomise a participant for Phase 2 trial.
- Site staff proved their flexibility and adaptability when Sponsor recruitment targets changed.
- 100% compliance to the study requirement of 24 hour data entry.
- Paratus Clinical's quality of participants, flexibility and speed contributed to the quick development of the vaccine.
Pneumococcal Vaccine Study
Background:This Study required healthy participants who where naïve of Pneumococcal Vaccination.
Requirement:To recruit 130 healthy volunteers who were pneumococcal vaccine naïve across the PCRN Network - 5 Australian and New Zealand sites.
- The 5 sites of the PCRN Network exceeded recruitment target by 130%.
- Capped recruitment for each site was increased as recruitment was so successful.
- Time from site activation to first patient screened at all 3 New Zealand sites was 2 days.
- Finding pneumococcal vaccine naïve participants in Australia was a recruitment challenge as it is a free vaccine for over 65 year olds however tagets were still exceeded
CBD Capsules for Sleep Disturbance Study
Background:This study required participants aged 18 - 75 years of age who had been experiencing a disturbed sleeping pattern. This was the first CBD investigational product study we have conducted at Paratus Clinical. It was conducted across all 4 of our GP sites.
Requirement:120 participants with history of disturbed sleeping patterns for the past 30 days and no previous medicinal cannabis use.
- Social Media advertising gained a lot of interest and we screened over 1000 potential participants
- Previous cannabis use was a big challenge for recruitment with cannabis being legal in ACT so many participants were excluded. Conversely in NSW and QLD, cannabis use is illegal so stringent recruitment was required in these states.
- Paratus Clinical exceeded our recruitment target for the study despite recruitment challenges related to cannabis use and gained more participants to our database who are keen to do similar trials in such an up and coming area of research.
Background:Sponsor company approached Paratus Clinical Research Woden to reconsider running their Phase 2 trial in the very rare condition, palmoplantar pustulosis (PPP) where site had previously declined due to unlikeliness to recruit.
Requirement:Sponsor requested site to enrol 1 patient for the potentially successful injectable biologic.
- Site enrolled 2 patients on the trial with the first patient enrolled being the first patient recruited globally.
- Outcome of the IP was hugely successful with PPP completely resolving for the patients.
- Very successful trial allowing patients relief from a high debilitating disease.
Gout PK Samples
Background:A small biotech company working with an Australian CRO looking for a site capable of long patient visits for their Ph2a Gout study.
Requirement:The study required 9 PK samples across a 10 hour period with no overnight stay.
- Patients were onsite for 12 hours +
- Patients were constantly monitored by site staff throughout this period
- Patients were provided with office space to work from, lunch and drink vouchers for local cafes and entertainment to fill in their time
Background:A Sponsor company working with an Australian CRO selected Paratus Clinical to be involved in a Hypercholesterolemia study for 20-80 year olds.
Requirement:The initial study recruitment timeline was reduced and Paratus Clinical was requested to recruit more patients to ensure target was met.
- Huge patient interest from our recruitment advertising
- Paratus Clinical exceeded recruitment target
- Recruitment completed in 23 days, Sponsor timelines met
Influenza Vaccine for Over-50 Year Olds
Background:A global influenza vaccine company working with an Australian CRO looking for a Southern Hemisphere site for an Influenza study.
Requirement:Study required 24 healthy volunteers over the age of 50 to be recruited 1 month prior to Australian flu season starting.
- Age range of participants and delay in study start up proved challenging for recruitment
- 3 Paratus sites recruited 80 participants in 7 weeks, this more than exceeded target
- Sponsor and CRO impressed with quality of patient data and study outcomes
Background:A multinational pharmaceutical company needed to speed up development timelines for a new vaccine study.
Requirement:The pharmaceutical company selected five sites in Australia(two from Paratus Clinical).Each site needed to recruit 12 women aged between 16-30 years of age.
- Paratus recruited 78% of Australian participants.
- Study recruitment closed on time.
- Speedy development of vaccine occurred.
Influenza Detection Diagnostic
Background:An Australian biotech company had developed a new point-of-care diagnostic to detect influenza and needed access to patients with ‘influenza-like illnesses’ within72 hours of symptom onset.
Requirement:Paratus worked closely with partner GP practices to set up referral pathways for eligible and interested patients, as well as setting up inside a GP practice to accommodate the study.
- Paratus recruited over 150 patients.
- The study was able to proceed with a statistically relevant number of patients.
- Development of the diagnostic tool was able to continue.
New Migraine Treatment
Background:An Australian biotech developing a new migraine treatment had experienced difficulty in achieving successful patient recruitment.
Requirement:The biotech company required fast recruitment after experiencing previous delays.
- Paratus delivered 120% of target in two months
- The biotech company was able to progress research to the next stage of development more rapidly than anticipated
Phase II Flu Vaccine Study
Background:A UK-based biotech company working with an Australian CRO required fast recruitment for a Phase II flu vaccine study.
Requirement:Biotech company needed 2,200 healthy volunteers during the 2019 flu season.
- Paratus recruited 893 participants (more than double the initial target).
- Fast recruitment expectations were accomplished.
- Paratus Western Sydney clinic was the highest recruiting site.
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