Consultancy Support

Over 30 years of clinical experience within the pharmaceutical and medical device industries.

Our clinical consultancy team is led by a senior consultant/clinical expert with over 30 years of clinical experience within the pharmaceutical and medical device industries. Our consultancy team has extensive experience in the field of clinical trials and in the planning and implementation of clinical programmes. We have also made significant global contributions to the development of both launched products and medicines.

Through our consultancy support programme, we offer a wide range of assessment and consultation services to help companies improve their clinical outcomes and efficiency. We are able to offer both practical and professional support to assist in the creation of clinical development plans and agency interactions. We also offer up-to-date, relevant advice and guidance on the ever-changing regulatory requirements for conducting clinical trials.

The work we undertake involves all aspects of clinical development from pre-clinical right through to post-marketing, as well as operational support.

We also offer comprehensive clinical research consultancy including Ethics Committee submissions, Trial Master File Management, Vendor management, and bespoke in-house training.

Project management

In addition, we have many years’ worth of experience working as senior project managers for a variety of global medical and pharmaceutical companies where we have effectively directed the activities of workers engaged in clinical research projects to ensure compliance with protocols and clinical objectives. Through this critical role, we have also undertaken responsibilities such as ensuring ethical research design, completing risk management activities, and assisting with data analysis.

Within this role, we have overseen activities such as:

• Establishing a plan or protocol to meet scientific standards and government regulation.
• Monitoring study activities to ensure compliance with protocols and with all relevant national and institutional policies, including: identifying protocol problems, informing investigators of problems, or assisting in problem resolution efforts such as protocol revisions.
• Maintaining required records of study activity including case report forms or regulatory forms.
• Instructing research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Overseeing subject enrolment to ensure that informed consent is properly obtained and documented.
• Gathering resources, ensuring that staff and equipment are available to perform required tasks.
• Maintaining safety standards to protect those involved in the trial.
• Remaining on schedule, ensuring the timely completion of each phase.
• Communicating with all trial partners as well as working with outside parties, such as regulatory authorities or physicians.
• Reviewing scientific literature, participating in CPD and education activities, or attending conferences and seminars where appropriate to maintain current knowledge of clinical studies, affairs and issues.

Our consultants can work on an hourly basis for as many or as few hours as you require. So, if you just want a few hours of advice or if you need someone to help guide you through your project, then we can help.

Contact our team today.

If you’d like to know more about our services or make an enquiry, please get in touch today using the contact details on the main page of our website.

We look forward to working with you,

The Lane Head team.