Clinical Trials and Services

Pharmaceutical Solutions provides a wide range of clinical trial services within Australasia. We offer the full suite of clinical trial management services, from early feasibility through to trial closure. In addition, we can provide study design, protocol development, and general data management services.

Our clients include some of the top global pharmaceutical companies, as well as established and early stage biotechnology and medical device companies.

We have a strong set of core values that are actively lived in the company. We are preferred partners with many of our clients. This is a direct result of our flexibility and responsiveness to client needs. Our superior staff competence is reflected in the consistent provision of quality data on time and within budget.

We manage clinical trials from Phase I to IV in a wide variety of therapeutic areas, with key expertise in Cardiovascular, Oncology, Endocrinology, Respiratory and Neurology.

Examples:

Cardiovascular

Hypertension
Acute Coronary Syndrome
Heart Failure
Cardiac Devices

Oncology

Multiple Myeloma
NSCLC
Colorectal Cancer
Prostate Cancer
Breast Cancer

Neurology

Multiple Sclerosis
Parkinson's Disease
Migrane
Acute Stroke

Haematology

Thrombosis Treatment
Prophylaxis & Recurrence/Prevention

Respiratory

Asthma
COPD
Cystic Fibrosis

Infectious Diseases

Hepatitis B
Hepatitis C
Pityriasis Versicolor

Endocrinology/ Metabolic

Osteoporosis
Type I and Type II Diabetes
Osteoarthritis & Rheumatoid Arthritis

Gastroenterology

Ulcerative Colitis
Crohn's Disease

Other

Active Psoriatic Arthritis, Acute Pain, Transplant Studies (Liver, Kidney, Heart), Diabetic Macular Oedema, Wound Closure Device, Respiratory Devices

Strategic and Regulatory Consulting

Pharmaceutical Solutions provides comprehensive, regulatory and strategic services.

These services cover the areas of clinical development, regulatory and marketing, each encompassing their associated elements, thus supporting the product's entire development cycle.

The high quality and timely completion of these services draws on our experience and knowledge of both the local industry and that of the greater Asia Pacific region.

Alliances and Partnerships

At Pharmaceutical Solutions we see innovation and collaboration as core requirements to manage the ever-increasing complexity of clinical trials. As the regulatory and compliance demands contribute to increase the costs of research, sponsors, trial sites, investigators and research, organisations must innovate and work together to delivery quality trial outcomes. In response, we are working in partnership with the sponsors, trial sites and other stakeholders to develop fit-for-purpose solutions.

Aliances and partnerships are structured to deliver the following benefits:

Efficiencies
Cost Savings
Resource Commitment
Creative Solutions

Based on our experience thus far, we are confident that through our exploratory process we can structure a working relationship that delivers benefits in quality, consistency, efficiency, and the bottom line - far beyond what's possible in a traditional outsourcing relationship. Together with our alliance partners, we can help advance the sponsor - site - CRO relationship to realise the true value of strategic outsourcing.

Pharmaceutical Solutions recognises the value in sharing associations to promote growth and opportunities within the clinical research industry.

Sharing our Expertise

We are proud of the knowledge and expertise of our diverse clinical team at Pharmaceutical Solutions and our combined experience in successfully managing clinical trials. Our team wish to contribute a series of articles which will cover a variety of topics; including recruitment strategies, fostering site relationships, time management and much more. Watch this space!

Part 1 - Successful Monitoring Visits

According to Good Clinical Practice, a Clinical Monitor serves to ensure that the rights and well-being of the subject are protected, that the data reported are accurate, complete and verifiable, and that the trial is being conducted according to the protocol and relevant regulatory guidelines.

At Pharmaceutical Solutions, we believe that thorough, well-planned monitoring visits are the cornerstone of successful management of any clinical trial. Our monitors focus on comprehensive preparation, conduct and follow-up of each visit we undertake and are encouraged to adhere to the following general guidance:

Preparation

Clarify and prioritise anticipated workload and tasks for the visit, including informed consent and eligibility review, serious adverse event review, verification of new patient data, follow-up of previous action items and planning for sponsor-specific requirements and special requests. Ensure timely pre-visit contact with site staff to ensure meetings are arranged in advance and appropriate confirmations are sent to site.

Conduct

Ensure the systematic work-through of tasks as identified during preparation. Be aware of sponsor-specific requirements or issues of current concern. Close relationships with sites ensures monitoring visits are constructive and worthwhile experiences. Maintain a flexible work attitude which can be adapted to suit the site. Ensure ongoing and thorough documentation during the visit to assist with comprehensive report writing. Continually develop and maintain knowledge of the resources available to ensure timely resolution of site questions.

Follow-up

Ensure delivery of a comprehensive, relevant and on-time report. Present concise follow-up correspondence with the Investigator, remembering to thank the site for its dedication and contribution to the study.