Accelerating clinical research to bring new treatments to patients faster.
Accelerating clinical research to bring new treatments to patients faster.
Impact Clinical specializes in three core areas of clinical research support. We offer:
Medical Writing: Comprehensive development of clinical and regulatory documents (for example, study protocols, informed consent forms, investigator brochures, clinical study reports, and submission dossiers). Our writers ensure each document is clear, scientifically sound, and ready for regulatory review, helping to communicate your data effectively.
Regulatory Submission Support: Guidance and hands-on assistance with submissions to health authorities like the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA). This includes preparing the required application sections, making sure all materials meet regulatory guidelines, and navigating the submission process from start to finish so that your interactions with agencies are smooth and successful.
Clinical Trial Services: End-to-end support for clinical trials, including trial planning, project management, site monitoring, and even providing experienced personnel to augment your team as needed. We can manage day-to-day trial operations or supply specific experts (such as clinical trial managers, monitors, or regulatory consultants) to ensure your study runs smoothly and adheres to protocols and timelines.
Impact Clinical collaborates with organizations of all sizes across the life sciences field. Our clients include:
BioPharma Companies: Large and mid-sized drug developers engage our team to handle specialized projects or to augment their internal resources for large-scale trials and complex regulatory submissions. We integrate seamlessly with in-house teams or manage standalone projects, depending on the client’s needs.
Biotechnology Startups: Emerging biotech companies may not have full in-house clinical or regulatory teams. We guide startups through early-stage trial design and first-time regulatory submissions, providing the expertise that helps them avoid pitfalls. Our support allows small teams to move forward confidently with their development programs.
Academic Researchers and Institutions: We support university-based researchers and hospital research centers in planning and executing their clinical studies. This can include writing protocols or grant-related regulatory documents, managing investigator-initiated trials, and ensuring compliance with regulations for those who may be less familiar with industry requirements. We tailor our approach to fit the academic environment and the experience level of the research team.
No matter the size of the organization, we adapt to your context. We’ve partnered with global pharma companies on multi-center trials and also helped first-time academic investigators navigate the basics of clinical research. Our goal is to provide the right level of support for each client.
Starting a project with Impact Clinical is straightforward and collaborative. Typically, the process involves a few simple steps:
Initial Discussion: We begin by learning about your needs. You can reach out to us via phone or email to schedule a free initial consultation. In this conversation (or meeting), we’ll discuss your project goals, the services you’re interested in (e.g., medical writing or trial management), your desired timelines, and any specific requirements or concerns. This helps us understand exactly what you’re looking for.
Proposal & Agreement: Based on the initial discussion, our team will put together a detailed proposal for you. This proposal will outline the scope of work, deliverables, estimated timeline, and a recommended approach. We’ll review the proposal with you and answer any questions. Once you’re happy with the plan, we’ll finalize a project agreement (which includes terms of work and typically a confidentiality agreement). Signing this agreement officially kicks off our partnership.
Project Kickoff: After the paperwork is in place, we organize a kickoff meeting with your team (either in person or via teleconference). In this meeting, we introduce the key members of your Impact Clinical team who will be working on your project. We confirm the project plan, set up communication channels, and establish a schedule for updates or check-ins. This ensures everyone is aligned and clear on expectations before work begins.
Once the project is kicked off, our team immediately gets to work on the agreed tasks. We keep you updated as we progress (see the next question on how we collaborate during the project), so you’re never left wondering about the status of your project.
We believe in working closely with our clients as true partners throughout the project. Clear communication and flexibility are at the heart of our collaboration. Here’s what you can expect when working with Impact Clinical:
Dedicated Project Lead: You will have a primary point of contact – usually a project manager or lead consultant – who oversees your project and is available to answer questions at any time. This person ensures our work aligns with your objectives and coordinates the rest of the Impact Clinical team.
Regular Updates: We provide frequent progress updates to keep you in the loop. This can include weekly or bi-weekly update calls/meetings, summary emails, and timeline reports – whatever format works best for you. You’ll always know what’s happening, what has been accomplished, and what’s coming next.
Collaborative Reviews: You are involved in key steps of the process. For example, if we’re writing a document for you, we will share drafts for your review and feedback well before anything is finalized. Your input is valuable, and we incorporate your feedback to ensure the final output meets your expectations. We can use your preferred collaboration tools or platforms (such as shared document portals or project management software) to make reviewing and editing convenient for your team.
Flexible Integration: Our team can operate as an independent unit or as an extension of your in-house team, depending on your preference. If you already have established processes or systems, we will adapt to them. If you need more hands-on support, we can take the lead in driving the project while keeping you closely informed. Regardless of the working model, we make it a point to respond quickly to your inquiries and remain flexible as your project needs evolve.
Throughout the project, we foster an open line of communication. You’ll always have visibility into our progress, and we encourage you to reach out with any ideas or questions. We want you to feel confident and informed every step of the way.
Timelines can vary widely depending on the nature and scope of your project. A smaller task—such as writing a single clinical study report or preparing a short regulatory briefing document—might be completed in a matter of a few weeks. Larger projects—like managing an entire Phase II clinical trial or compiling a full FDA submission (which includes many documents and data analyses)—can span several months to a year or more. We’ve managed projects across this entire spectrum, so we tailor our timeline to fit the work at hand.
At the outset of every project, we will discuss your target timelines and any critical deadlines you have. We strive to align our work plan with your schedule. Impact Clinical is accustomed to working under tight deadlines; if you have an aggressive timeline, we will mobilize resources quickly and efficiently to meet it. Our team has experience meeting rapid turnaround requirements without compromising quality.
Throughout the project, we also closely track progress against the timeline. We’ll let you know if we are ahead of schedule or if any challenges arise that might affect delivery dates. This way, you’ll always have a realistic view of when to expect milestones and deliverables, and there won’t be any last-minute surprises.
Confidentiality is fundamental to everything we do. We understand that your data, results, and proprietary information must be protected. Here are some of the ways we safeguard your project’s confidentiality:
Confidentiality Agreements: We typically sign a Non-Disclosure Agreement (NDA) with our clients at the start of an engagement. This legal agreement ensures that all information you share with us is legally protected from disclosure. In addition, every Impact Clinical employee or consultant is bound by strict confidentiality obligations in their employment contracts, which means they are required to keep client information private.
Secure Data Handling: We use secure systems and tools to manage project information. Access to your documents or data is limited only to the team members who need it for the project. We follow best practices for data security — including password protections, encrypted storage when appropriate, and secure file transfer methods. If your project involves sensitive personal data (for example, patient information), we comply with all relevant privacy laws such as HIPAA and GDPR to ensure that data is handled appropriately and anonymously.
Internal Policies & Training: All Impact Clinical staff are trained on confidentiality and data protection procedures. We have clear internal policies on how to handle client information, and we regularly reinforce these policies. For instance, we avoid using email for extremely sensitive files (opting for more secure transfer methods) and ensure that any printed materials are stored or disposed of securely. Our culture emphasizes caution and discretion when dealing with client data.
Need-to-Know Principle: Within our team, information about your project is shared on a need-to-know basis. This means even internally, we only disseminate your information to individuals who are directly involved in your project. By minimizing unnecessary access, we further reduce any risk of inadvertent disclosure.
Professional Ethics: Beyond formal agreements and technical measures, we take pride in our professional integrity. We treat your intellectual property and research data as if it were our own. You can trust that we will never share or discuss your project details with anyone outside of Impact Clinical (unless you’ve given explicit permission for us to coordinate with a third party).
In short, your information is safe with us. We understand the high stakes of clinical research and innovation, and maintaining your trust through strict confidentiality is our priority.
Ensuring compliance with all regulatory standards and guidelines is a top priority for Impact Clinical. We incorporate quality and compliance checks at every stage of our work so that everything we do meets the expectations of regulatory authorities. Here’s how we maintain high compliance standards:
Adherence to Industry Guidelines: We follow all relevant regulations and guidelines, such as the ICH Good Clinical Practice (GCP) guidelines, FDA and EMA regulations, and other international standards for clinical research. This means that when we design a study, manage a trial, or prepare a document, we do so in a way that aligns with the established rules. For example, our clinical trial processes ensure proper informed consent and ethical conduct, and our documents are formatted and structured according to regulatory requirements.
Experienced & Trained Team: Our team members are well-versed in regulatory requirements. We invest in continual training so that our staff stays up-to-date with the latest changes in guidelines or expectations from regulators. When you work with Impact Clinical, you’re leveraging a team that may include former industry regulators, seasoned clinical research professionals, and regulatory writers who have successfully handled many submissions. This collective expertise means we often know what regulators will look for, and we plan accordingly.
Quality Control & Review: Quality assurance is built into our process. Important deliverables go through multiple rounds of review. For example, if we prepare a regulatory document for you, it will be reviewed by a senior reviewer or editor for accuracy, clarity, and compliance with guidelines before you ever see it. We also perform checks against regulatory checklists to ensure nothing is missed. These internal quality control steps help prevent errors and ensure the final output can withstand regulatory scrutiny.
Regulatory Intelligence: We keep abreast of the regulatory environment. This means we monitor updates like new FDA guidance documents, EMA guidelines, or ICH updates that could impact your project. If, for example, the FDA issues a new recommendation on trial design or data presentation in the middle of your project, we will know about it and can adapt our approach so that you remain in compliance. We can also advise you on the implications of such changes.
Proven Track Record: Over the years, we have supported numerous successful regulatory submissions and clinical trials that passed audits or inspections. Our experience includes dealing with FDA inspectors during GCP inspections and answering questions from ethics committees and institutional review boards. This experience gives us practical insight — we don’t just understand the theory of compliance, we know how it plays out in real-world scenarios. We bring those lessons learned to your project to ensure everything is done right the first time.
By combining a knowledgeable team with strict processes and continuous vigilance, Impact Clinical makes sure that your project remains fully compliant with all regulatory and ethical standards. This focus on compliance ultimately protects your research and increases the likelihood of a smooth approval process.
Preparing a regulatory submission can be one of the most complex parts of bringing a new therapy or device to market. Impact Clinical provides comprehensive support throughout the submission preparation process to help ensure your application to agencies like the FDA or EMA is complete and of high quality. Here are some ways we assist with regulatory submissions:
Submission Planning: We start by mapping out a clear plan and timeline for your regulatory submission. This involves identifying all the pieces required for the application (for example, administrative forms, quality/manufacturing information, nonclinical study data, clinical trial data, and summaries). We’ll create a checklist and schedule so that nothing is overlooked and each component is prepared in a logical order. Our team can also advise on regulatory strategy – for instance, determining the best time to request a meeting with the FDA or how to sequence submissions if you plan to seek approval in multiple regions.
Document Preparation: Our medical writing experts can draft or compile every section of your submission dossier. Whether your application requires detailed clinical study reports, summaries of safety and efficacy, patient narratives, investigator brochures, or any other specialized documents, we make sure each component is clearly written, scientifically accurate, and in the correct format. We pay close attention to consistency across documents (so that data references and terminology match everywhere) and ensure that any necessary data tables, graphs, and appendices are included and properly referenced.
Formatting and Technical Compliance: Each regulatory agency has specific formatting requirements for submissions. We make sure your submission adheres to these technical requirements. For example, if you’re submitting to the FDA, we ensure that the submission is structured in the electronic Common Technical Document (eCTD) format and that file formats, naming conventions, and folder structures meet FDA guidelines. Similarly, for an EMA submission, we follow the EMA’s submission portal requirements. By handling these technical details, we reduce the risk of your application being delayed due to formatting issues or technical rejections.
Review and Quality Checks: As we prepare the submission documents, we conduct thorough quality checks. This includes verifying data against source documents (to ensure accuracy), editing for clarity and correctness, and checking that all regulatory questions are answered. If you have internal teams (e.g., your own scientists or regulatory officers), we will coordinate review cycles with them as well, incorporating their expertise and ensuring everyone is confident in the content. Essentially, by the time the submission package is ready, it will have gone through multiple rounds of scrutiny to catch any errors or omissions.
Liaison with Regulatory Experts: If needed, we can act as a liaison between your team and external regulatory consultants or even directly with the agency. For instance, some clients engage us to prepare their FDA meeting briefing packages and also have us attend the meeting to support the presentation and discussion. Our team’s familiarity with the process can be reassuring during interactions with regulators. We speak their language and can help translate any feedback you receive into actionable steps.
Final Assembly and Submission Support: When all components are finalized, we assist in assembling the entire application for submission. This might involve compiling hundreds of files into a cohesive package. We double-check that all required documents (and electronic submission metadata, if applicable) are present. If you prefer, we can handle the actual submission as well – for example, uploading the files to the FDA’s Electronic Submission Gateway or the EMA’s online submission system. Throughout this phase, we coordinate closely with you to ensure timing is right (submissions often coincide with certain internal or investor timelines) and that you have a complete copy of what’s being submitted for your records.
By offering support at each step – planning, document preparation, quality control, and the final submission process – Impact Clinical helps take the stress out of regulatory submissions. Our goal is to make sure that when your dossier arrives on the regulator’s desk, it’s thorough, well-organized, and poised for a positive review.
Yes. Our support doesn’t end once the submission has been sent to the regulatory agency – we remain by your side throughout the agency’s review period and up to the final decision (and even after). Here’s how we support you during the review and approval process:
Handling Questions and Information Requests: It’s common for agencies like the FDA or EMA to ask follow-up questions or request additional information while they evaluate your submission. When queries come in (for example, an FDA “information request” letter or an EMA list of questions), our team jumps into action. We help you understand exactly what the regulators are asking for, and we assist in preparing clear, thorough responses. This might involve writing response documents or addendums, pulling in our medical writers, statisticians, or other experts to address specific points. Our goal is to help you reply promptly and satisfactorily to all questions, which can keep the review process on track.
Post-Submission Updates and Amendments: Sometimes during a review, you might need to submit additional data or make amendments (for example, maybe new safety data became available, or a minor correction to the submitted documents is needed). We assist with preparing any follow-up submissions or amendments. Because we were involved in the original submission, we can quickly integrate new information in the correct format. We’ll also ensure any new documents undergo the same quality checks as the original submission.
In summary, we don’t consider our job done until you have a clear resolution from the regulatory agency. Navigating the review process can be as crucial as the submission itself, and Impact Clinical will be there to support, advise, and act on your behalf so you can achieve the best possible outcome.
We’re always happy to answer any other questions you have about our services or how we work. If something isn’t covered on this FAQ page, or if you need more details, please feel free to reach out to us directly. You can contact us by phone at +1 (760) 715–4539 or by email at info@impactclinical.com. Additionally, you can use the contact form on our website to send us a message at any time.
Our team is friendly, responsive, and ready to provide the information or support you need. Whether you’re a prospective client exploring options or a current client with a new question, we’re here to help in any way we can. Don’t hesitate to get in touch – no question is too small or too basic. Your success is our priority, and that starts with having all the information you need.
Let’s discuss your project needs.
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