Supervision of clinical activities, including selection and management of an appropriate CRO, is critical to clinical trial progress. Clinical operations includes: reliable communication between the Sponsor and CRO, accurate site feasibility assessments, effective patient recruitment, enhanced communication with clinical sites, thorough clinical site monitoring, and creation of comprehensive protocols and clinical study reports (CSR). We are ready to share our expertise in the following clinical operations areas: Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), and Clinical Program Manager (CPM).
Safety management and medical monitoring in your therapeutic indication can provide your organization with effective assessment of eligibility and enrollment-related issues, oversight of serious adverse event (SAE) reporting, and narrative review for accuracy and correct medical coding. Medical oversight is also essential in the development of your clinical study protocol and can enhance your interactions with Key Opinion Leaders (KOLs) and Investigators. Our medical and safety consultants will work to foster consensus during safety meetings, and ensure accurate presentation of clinical data within regulatory filings. Development Insights can bring flexible and scalable medical expertise to your team.
Regulatory oversight of the development process is vital to the success of any investigational product. Development Insights regulatory consultants are equipped with the experience needed to steer your product toward the marketplace. Our services include:
Regulatory Strategy: Our regulatory strategy professionals can guide you through the planning and execution of your Target Product Profile (TPP). Tactical plans will be developed to enhance value, whether your plans include an expedited development and review program, proof of concept (POC) licensing transaction, orphan indication application, or registration in multiple regions.
Regulatory Affairs: Technical development and review of your regulatory filings will ensure accuracy and a consistent message. Our regulatory affairs consultants can work with your team to develop phase-appropriate, clear, and concise documents to support both domestic and global submissions.
Regulatory Operations: Our regulatory operations professionals can assist you with selection of an appropriate electronic vendor to allow for quick and efficient submission of your documents to regulatory agencies. We can also provide training in the use of document templates and formatting, manage the submission review process, and provide lifecycle management for your regulatory filings. By acting as the liaison with your chosen electronic vendor, we can also reduce the costs associated with document quality control (QC), and will provide a review of the filing against current industry guidance.
Quality Management is crucial to ensure product integrity and patient safety. Whether you are a virtual start-up who needs to develop and implement a compliant Quality System, or a larger company who needs additional talent to support your existing quality group, Development Insights can provide the solution.
Quality Documentation Systems: Document management is a key component of a robust Quality System. We can develop appropriate standard operating procedures (SOP) for your organization, create your document repository, and provide clear processes for managing revisions and historical maintenance.
Quality Assurance Audits: Our consultants are experienced in conducting internal audits, as well as audits of vendors performing regulated activities (GLP, cGMP, GCP) to ensure quality products and services.
Agency Inspection Support: We have extensive experience interacting with regulatory agencies, addressing inspection findings, and preparing organizations for inspection.
Quality Assurance Document Review: Development Insights consultants have the technical and industry expertise to review your regulated documentation (manufacturing, nonclinical, and clinical), as well as associated regulatory filings, for technical accuracy and compliance with regulations and industry guidance.
Sometimes, having all of the pieces isn’t enough. Multi-disciplinary development teams need a leader who will develop and drive a program toward a corporate goal. Incorporating the plans of each discipline into an integrated project plan, highlighting program milestones and risks, and running effective project team meetings is how a program manager brings value. The key to successful program management is having an in-depth understanding of the development process and being able to guide the team through execution of a thoughtful and cohesive project plan. Our program managers help your project stay on course, and provide the expertise to coordinate team members, while effectively adapting to the challenges of clinical trials.
Many of our clients are ultimately looking for a partner to propel their product to commercial approval and distribution. Others are thinking of in-licensing a product, or looking themselves for an acquisition. These scenarios are becoming commonplace in the life science product development marketplace. Our experienced alliance management team members can aid in refining your message, supporting due diligence activities, developing investment terms and structures, and managing the intricacies of a partnership or acquisition. Strategic guidance can make the difference in maximizing market appeal and realizing your goals.
Chemistry, Manufacturing, and Controls (CMC)
Development and management of a seamless manufacturing supply chain is critical to the success of your product. We understand that in order to realize this success, our clients may require assistance in: development of specifications, determination of appropriate in-process controls (IPC), phase-appropriate validation of analytical test methods, stability study design, as well as writing CMC sections of regulatory filings. Our team members can provide expertise during the development and scale-up of your manufacturing process, including the selection of qualified manufacturing and testing vendors to propel your product into nonclinical testing, clinical development, and ultimate commercialization. Whatever your needs in CMC are, we can provide a flexible solution for you.
The development of indication-specific nonclinical testing programs to support the conduct of clinical trials is a specialty at Development Insights, and we understand its importance to your success in clinical development. Our nonclinical and translational research team members have expertise in: design of IND-enabling toxicology studies, bioanalytical method development, evaluation of TK/PK data, biomarker selection, and technical review of study protocols and reports. In support of regulatory filings, we can write nonclinical sections, and also provide support in the development of associated clinical documents, such as the Investigator’s Brochure (IB) and Informed Consent Form (ICF). Development Insights can provide the industry knowledge to ensure that your nonclinical testing pathway will augment your clinical development plans.
It’s all about significance. Developing an appropriately powered clinical study, knowing where and when interim analyses should be performed, and experience in relational data mining are all important when it comes to interpreting clinical datasets. Project teams which incorporate proven biostatistical expertise into the design of a clinical study increase the odds of success, which could lead to expedited Agency review pathways. Our biostatisticians take the time to understand your product, the indication, the proposed clinical assessments, and approved standards of care. Let our experienced biostatisticians provide expertise in strategy, sample size, and data analysis, in order to yield reliable and significant results.
Clinical Data Management (CDM)
Comprehensive data management is the cornerstone of a successful clinical trial. Having the right person in place to assist with electronic case report form (eCRF) development and testing, proper review of data queries, implementation of data management plans, and relational analysis are just a few areas where experienced data managers enhance trial performance. By overseeing these activities at your CRO, assisting with the selection of appropriate database tools, reviewing vendor change orders, or assessing performance metrics, our data managers provide the expertise allowing for a closer relationship and better understanding of the status of your trial data.