Due to its strong scientific background and long-term expertise in planning and conducting clinical trials, FHS’s team of experts offers a broad spectrum of activities in the field of scientific and regulatory consultancy and services for clinical drug development with a focus on conceptual and strategic aspects consultancy.
Project assessments, external clinical development expertise, additional clinical pharmacology expertise for complex project issues and crucial decisions (second opinion)
Development strategy and concepts, life cycle management, drug rescue concepts, bio-pharmaceutical concepts, add-on expertise and resource in conceptual matters and study design issues
In addition to our study related medical writing services, FHS can prepare expert reports and publications
Support in identification and selection of specialized non-clinical and bioanalytical service providers, support in establishment of co-operations and partnerships
Preparation and conduct of workshops and seminars in clinical pharmacology, pre-clinical/clinical interface, early drug development
Regulatory Affairs
Regulatory requirements are continually evolving and furthermore vary from one country to another.
To get the right strategy and moreover the different activities required across globe to undertake clinical trials in line with national guidelines, our regulatory and clinical operation teams have extensive experience.
Whether the internal experts or external cooperation partner for dedicated countries, both will cooperate and guide the client to have all necessary documents together on time.
1.Understanding and interpreting the ever-changing regulatory environment
2. Preparation and submission of clinical trial submissions
3. Interaction with regulatory agencies world-wide
4. Preparation of country-specific documentation and submissions
5. Preparation of end-of-trial declarations
6. Preparation & submission of medical device trials
Feasibility
Identifying, screening, qualifying and motivating investigational sites are an ongoing challenge for every clinical study. The more accurate the initial feasibility assessment for site identification is, the more successful the study will be. As a result, the projects will be delivered on time and completed within budget.
Is the study itself feasible? Are patients existing fulfilling all in- and exclusion criteria? Is the patient willing to run through all assessments required in this trial? Answering these questions utilizing experts in the dedicated indication and region makes recruitment predictable, controllable and helps to ensure that it is done within time and budget.
For each project, a member of the clinical operation team is appointed to oversee the feasibility for both, recruitment capacity and protocol and is supported by a dedicated team of local CRAs to manage the individual countries. With rich experience and a broad network of Key Opinion Leaders (KOLs) and Investigators, the team has access to a large pool of sites to involve in study feasibilities across a variety of therapeutic indications and geographies.
Medical Writing
The key to professional success for researchers is the precise presentation of scientific ideas and results, which helps maximize the accuracy and impact of written documents. Although medical and clinical research professionals are experienced in the fields of medical and clinical research, expertise in the field of regulatory science writing and publication of scientific papers is still a gap, and FHS has converted this into an asset by a scientific medical writing group.
At FHS, our writing staff has the professional background, skills and long-term clinical study, as well as therapeutic, experience to provide expert support at every stage of development for drugs, biologicals and medical devices. We work in accordance with FDA, EMA and ICH guidelines and regulations to deliver a wide range of clear, concise clinical documents and publications on time and in harmony with your company’s style and format.
1. Protocol and Clinical Investigation Plan Development and Amendments
2. Integrated Clinical Study Reports
3. Common Technical Document Summaries and Overviews
4. Clinical Expert Reports Including ISE and ISS Formats
It is our people that make the difference and the effective training that assures excellence. That's why we invest in our clinical monitors through training and continued professional development. We ensure that our monitors are always up to date with local and international standards and we as the majority of our partners are members of local clinical research associations in their respective regions.
The clinical monitoring team is designed to closely work with the project management team in order to ensure that your study is executed precisely. The geographic distribution of our freelance team lends itself to operational flexibility and efficiency all while keeping the client’s best interests in mind: being accurate and cost-effective.
Monitors are the representatives of FHS and client’s study towards the investigators. This is why we assure best communication skills and performing quality checks on the investigator site frequently. Having a good relationship is one of the best motivations for investigators to follow the recruitment plan as scheduled.