CLINICAL OPERATIONS

Start up Activities - Monitoring - Clinical Trial Management
Clinical Consulting - Audit & Inspection Readiness - Outsourcing

C

reative Pharma & HR Services offers full Clinical Trials services and support through the entire clinical trial conduct: from Protocol Concept to Clinical Study Report (CSR). Our Clinical Trials Team has been founded by a Group of experts with multinational and diverse experience in Clinical Operations of more than 20 years.

Our Team of experts with advanced managerial efficiency and in-depth understanding of the rapidly evolving Clinical Trials Landscape can up level any clinical trial related activity such as: strategic design advice, critical decision making, clinical trial oversight/management.

In Creative PHS we utilize Technological Advances and put Simplicity and Creativity to complex procedures.

SOLUTIONS

Feasibility

To make clinical trials more efficient and effective at each phase of the drug development journey.

Creative’s Feasibility group provides comprehensive study feasibility assessments for clinical trials. Using real-time feasibility surveys in conjunction with Creative’s operational experience to better position our sponsors’ trials for success.

Site Identification and Selection

To accelerate study start-up and improve clinical trial execution.

Identifying and selecting the right investigative sites is paramount for successfully completing a clinical trial. Creative’s Site Intelligence Team follow a data driven approach to collect, analyze and assess the information required to select the best sites is considering both timely enrolment and high-quality data.

Clinical Consultancy

To help shape our client’s organizations and create advise solutions for client’s most complex challenges.

Clinical Consultants have a deep interest in the ways people, strategy, operations and process improvements guide the future of our clients. Creative offers flexible, high-level expertise by an individual consultant or by a complete Clinical Research Team, containing profiles provided by us and selected by the client, on an insourced or outsourced basis. Creative’s Clinical Consultants can function on site, using the clients’ tools, together with other Team Members working on the project. Our consultants can also work at the client’s premises, be home based, or work from Creative’s offices.

Scientific Leadership

To transform site performance.

Strengthening recruitment and data quality, building mutually beneficial and collaborative relationships with the investigator sites and maintaining motivated and engaged investigators is a key role for the Creative Scientific Leadership Team. Site engagement using the scientific leadership model enables active peer-to-peer communication and action pathways between the investigators, study teams, and the sponsor.

QUALITY IN A SERVICE OR PRODUCT IS NOT WHAT YOU PUT INTO IT. IT IS WHAT THE CLIENT OR CUSTOMER GETS OUT OF IT.
– PETER DUCKER

Clinical Trial Regulatory Services

To achieve fast, compliant and cost-effective clinical trial applications.

Creative’s Regulatory Consultants offer solutions either standalone or integrated into a full clinical trial management service. Considering that Regulatory Services require the input from multiple departments and that clients may work with multiple partners to develop a clinical product; our solutions and process offer maximum flexibility and are tailor made to your needs. Whether you, Creative or a third party manages the clinical trial, Creative’s Clinical Trial Regulatory Services offer flexibility with fast cost-effective submission solutions.

Clinical Trial Agreements

Developing, Negotiating, Executing Clinical Trial Agreements.

Clinical Trial Agreements allow for allocation of risk, responsibility, funds, obligations, and the protection of academic, legal, intellectual property and integrity. Creative’s experts manage the risks and ensure a asuccesful contract is in place for the parties invloved. They succesfully prepare, negotiate, review and execute the clinical trial agreement whether it is with an Insdusdtry Sponsor, for an Investigator Initiated Clinical Trial or with an Academic Institution.

Clinical Trial Outsourcing

Tailormade Solutions to fit your needs.

Creative understands your need to select the outsourcing solution that aligns with your own approach to development. Creative’s expert will partner with you through the process to develop a model which offers the best clinical trials outsourcing solution for your specific needs.

Experienced, qualified and highly skilled clinical trial professionals are provided by Creative to cover your outsourcing requirements. Whether you need short term ad hoc placements, or placements to integrate with your own workforce. To fully leverage Creative’s Capabilities our Clinical Department can also manage your projects on a partnership-based model.

Creative can procure on your behalf local certified vendors best suited to cover the needs of your clinical trial. The process entails identifying and proposing options for the client to choose from, prepare the prospective offers, undertake the contract negotiations and execution

Clinical Trial Monitoring

To safeguard subject safety, data quality, and protocol compliance.

Creative’s monitoring methodologies promote a closer relationship with the site with a preventative focused on quality approach. Creatives monitors have all data available and are ready to help with issues as they arise, supporting the site in near real-time.

There is mounting evidence that a Risk-Based Monitoring (RBM) methodology can improve the clinical oversight process and do so at a lower cost through more intelligent deployment of monitoring resources to the sites that need more attention. RBM combines centralized and off-site review of important study parameters with an adaptive on-site monitoring approach that places greater emphasis on risk-mitigation activities.

Creative understands that individual sponsors have various experience and comfort-level with RBM. Our flexible approach allows Creative and our clients to identify the best study-specific monitoring strategy that aligns with the study-specific risks identified during the planning phase.

AN ORGANIZATION’S JOURNEY TO EXCELLENCE BEGINS ONCE IT CEASES TO SACRIFICE QUALITY FOR SPEED.
– NEIL BEYERSDORF

Clinical Trial Management

Optimizing Clinical Trial Operations.

As today’s medical field is being rapidly advanced, clinical trials serve the essential purpose to determine the safety and effectiveness of medical treatments and devices. To ensure smooth operation of clinical trials in context of current local and European legislation, qualified professionals are necessary. Highly experienced Clinical Trial Managers and Management Teams in Creative’s workforce are responsible for directing the process of clinical trials by employing effective strategies and reviewing the results using rigorous clinical procedures. Focus of clinical management is planning, coordination, overview and evaluation of all the activities performed by multidisciplinary teams to ensure the delivery of high-quality solutions.

Audit Inspection Readiness

Get it right the first time.

Audits and inspections are a common fact when running clinical trials. The best inspection preparation occurs where a culture of readiness is embedded within an organization. This kind of culture is embraced by Creative’s Clinical Team which is constantly working to ensure the high quality of ongoing clinical studies. Maintaining a state of inspection readiness requires vigilance and expertise, but also pays off¬ in sta¬ff knowledge and confidence, enhanced quality, and operational systems in a state of continuous improvement.

THERAPEUTIC AREAS
  • Oncology / Hematology
  • Cardiology
  • Ophthalmology
  • Rheumatology
  • Dermatology
  • Respiratory
  • Immunology
  • CNS
  • Endocrinology
  • Rare Diseases
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