Summary: Our client, a rapidly growing clinical-stage pharmaceutical company in the greater Boston area, needed help managing a regulatory submission process.
Challenge: Aggressive timelines/deadlines
Solution: Beacon Hill Pharma assisted in ramping up their Regulatory Affairs team in preparation for a handful of IND submissions. Our client lacked the internal expertise to manage the submission process and to meet their aggressive deadlines.
Result: Beacon Hill Pharma provided multiple resources at various levels (Senior Managers, Managers, and Submissions Specialists) to oversee the development and successful submissions of INDs for multiple prospective products. Beacon Hill tripled the size of our client’s Regulatory team and look forward to assisting them with future growth as well.
Summary: a fully integrated pharmaceutical company out west needed our help with an executive placement
Challenge: The role had been open for some time and 2 other firms had failed in filling this role.
Solution: Beacon Hill Pharma’s executive placement team sourced, screened, interviewed and presented 3 qualified candidates to the client.
Result: Beacon Hill Pharma successfully placed a VP level candidate who is thriving in their role.
Summary: An existing client, a clinical-stage pharmaceutical company in the greater Boston area, requested that Beacon Hill Pharma provide support within their Clinical Operations and Clinical Data Management departments.
Challenge: With dozens of trials on the books for 2015, our client needed additional support to review and create electronic CRFs, manage data transfer agreements between vendors and CROs, and to assist with cleaning data for these trials.
Solution: Quickly provide qualified resources that meet the company culture.
Result: Beacon Hill Pharma continues to provide all aspects of Clinical Data Management support to this client for current and future trials. Additional responsibilities have included QC of data, validation of database structure, providing status reports, and ensuring the Clinical Data Management team is adhering to current GCP and ICH guidelines.
Summary:A rapidly growing Biologics company needed support with a team of clinical document associates.
Challenge:Team needed to be implemented right away and they needed to have the ability to work a great deal of hours.
Solution:Beacon Hill Pharma’s local team reached out to their proven network and came up with multiple candidates to complete the team.
Result:The client is very pleased with the customer service and quality of work by both the contracted team and Beacon Hill.
Summary: A large Biotech firm in the greater Boston area asked Beacon Hill Pharma for help with project management services.
Challenge: Our client required assistance with project management support for cross functional departments within their organization in fast timeline.
Solution: Beacon Hill Pharma provided resources to assist their Clinical and Medical Affairs departments with project planning, budgets management, meeting preparation and summarization, and general project management responsibilities.
Result: Our client was so pleased with the resources provided, that several of our Project Managers were offered permanent employment at the client, following this engagement.
Summary: A Midwest, global biopharmaceutical client of ours needed project management/program management support.
Challenge: Due to this being a very unique skill set, the client had tried to obtain this skill set from other sources with no success.
Solution: Beacon Hill Pharma leveraged its best-in-class network to find a resource that fit the specialized skill set.
Result: Beacon Hill presented a qualified resource within 48hrs and the candidate started the contracted project in 2 weeks. The client is very happy with the results.
Summary: A pharmaceutical company in the greater Philadelphia area requested our help with Pharmacovigilance/ Drug Safety support.
Challenge: Assist with case processing for a reconciliation project.
Solution: Beacon Hill provided several qualified resources with medical backgrounds (RNs) and clinical case processing experience to assist the team.
Result: This is an ongoing project for Beacon Hill Pharma and we’re actively working to ensure that all deadlines are met successfully. We have routinely assisted clients with similar positions and can scale up our PV teams to meet any project requirements.
Summary: A growing device company needed to grow their team quickly across the country.
Challenge:They did not have headcount available to hire and needed qualified resources at multiple locations across the country.
Solution: Beacon Hill leveraged in National recruitment team to find 4 different unique skill sets in 4 locations.
Result: Beacon Hill Pharma successfully placed 4 contractors with the Device Company and they have been very happy with the success of the projects.
Summary: A Specialty Pharmaceutical client of ours asked for help with a senior level regional monitor.
Challenge: The role had been filled by another company previously and the performance was lacking in quality.
Solution: Beacon Hill Pharma reached out to our unmatched Clinical Monitoring network to identify a resource.
Result: Beacon Hill Pharma identified 3 candidates in 48hrs. The client was very happy with all 3 candidates and hired their top choice. The project is moving along successfully.
Summary: A growing biopharmaceutical company asked us to support with Auditing project.
Challenge: The client needed a fast response and qualified resources that could meet their unique needs.
Solution: Beacon Hill Pharma leveraged our virtual auditing teams, comprised of GCP, GMP, GLP, PV, and CSV experts who can be deployed on short notice to various sites to meet all of our clients’ auditing needs.
Result: Beacon Hill Pharma was retained for both a small auditing project and full scale inspection readiness initiatives to include TMF review, and investigator site readiness.
Summary: A start-up gene therapy biopharmaceutical client partnered with Beacon Hill Pharma to build and staff a new group of associates within their manufacturing group that were dedicated to the sterilization of their aseptic modular clean room.
Challenge: Our client required this to be completed under strict timelines and in addition to building job descriptions for the roles. This project is continuously ongoing therefore a steady flow of candidates is necessary.
Solution: Beacon Hill Pharma assigned the project to our dedicated biologics recruitment team and staffed the project effectively within 30 days.
Result: Our client was very impressed with our results that we continue to manage this ongoing project nearly 3 years later exclusively within our firm. We’ve built strong relationships with manufacturing managers in addition to adjacent departments such as: Manufacturing Science & Technology, Quality Assurance, and Engineering.
Success Story: Beacon Hill Pharma recently placed a PV team consisting of 4 PV Medical Directors and 4 PV Scientists to assist a small, oncology-based pharmaceutical company in preparing for their first NDA submission of their flagship product. The company had a small, established PV department prior to engaging with Beacon Hill Pharma, but lacked the bandwidth for completing the Integrated Summaries of Safety, Benefit-Risk evaluations (specifically pertaining to cardiotoxicity), safety update reports, risk management plans, and other various PV materials. Under management of the VP of Pharmacovigilance, Beacon Hill Pharma delivered a combination of on-site and remote resources to meet the aggressive deadlines and to bring additional industry expertise to their team during this critical time.