Clinical development strategy and study design guidance

Expert clinical Trials provides clinical development strategy and study design guidance to biopharmaceutical companies and medical research institutes.

We add value across the clinical development lifecycle from Phase I studies through to Phase IV with sound regulatory insights, design options, gated target planning, study complexity, implementation and location advice.

Specialists at Expert clinical Trials work with you to tailor your clinical studies and development programs, decrease risk and meet regulatory, developmental, commercial, budget and time objectives.

Local, regional and global level management

Clinical Project Management

Expert clinical Trials serves experience, scientific knowledge and operational expertise combine with responsibility and integrity to create a powerful value proposition for the pharma and biotech companies.

Our experienced Project Managers coordinate all activities related to the study, manage its timelines and budget and maintain close communication with sponsor, project team and sites.

Project Management group works on keeping each project on time and within planned budget.

Each Project Team is motivated and integrated, with local expertise and therapeutic experience and knowledge.

We are providing personalized service that meets the needs of customers of all sizes for projects of every scope.

Our project management team works closely with the scientific team to ensure the smooth progression of your clinical trial.

Our Project Managers work effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output.

 Our team will work with you on every aspect of the trial from the first regulatory submissions through to closeout and final reporting to help you and guide your project to succeed.

Medical Writing Services

We offer Comprehensive, reliable medical writing support to expedite submissions and approvals. Our medical writing services are offered as an integrated part of our clinical development expertise and include Protocol development, ICF, Investigator Brochure, Clinical Study Report Writing and Regulatory Writing.

  • Phase I-IV protocol development
  • Clinical study reports according to ICH E3 and eCTD format
  • Translations of regulatory documents
  • Investigator’s brochure development
  • SOP development
  • Informed Consent Form including local language ICFs

Clinical Research Consulting

Our consultants work with you to design early phase studies and develop programs that manage risk are cost and time efficient while being effective for your development needs. We strive to bring promising new therapies to patients faster, resulting in cost and time savings for your company and more importantly, impacting patients’ lives.

Every client we work with has different  early phase study needs, clinical development intentions and commercialization goals. We work with you to ensure workflow, proactiveness and value driven approach deliver a personalized service to meet and even exceeded expectations

  • Our team has the knowledge to support your needs throughout the product lifecycle. This includes defining the regulatory development strategy, producing clinical trial and marketing authorization submissions, etc.

Our experienced team not only helps you create your strategic clinical development plan, but also provides tactical support to develop the clinical trial design; determines sample size calculations; writes, edits or reviews protocols and so on.

Our team will guide you in planning targets and develop strategies to help you in reaching them.

We use an out-of-the-box thinking approach to produce creative solutions that will help you meet your development goals faster.

Each project is unique and has its own set of challenges and complexities related to its design or regulatory strategies. Our team will be there to identify possible pitfalls and proactively  solve them, resulting in time and cost benefits for you.

Having experience with recruiting for many studies across therapeutic areas we know what  geographical locations may work better for recruitment . Choosing the right locations for your studies, this simple action can be the deciding factor between success & failure.

With years of successful clinical research submissions to regulatory agencies, our team of consultants has a specialized skill of clear and precise writing. We are able to assist you with protocol writing, study reports, IB and other essential documents.